Scott
Well-known member
I was on the Coaguchek websit and noticed a "urgent medical device correction" so I thought I would pass it on. http://www.coaguchek.com/landing/
Attention: Patient Self-Testers
CoaguChek XS System — Cleaning-Related Malfunction of Meter with Potential to Impact Results
Issue___________________________________________________________________________________________
Internal investigations have confirmed that recommended cleaning procedures for the CoaguChek XS system can, in rare circumstances, cause a meter malfunction which could lead to falsely elevated results.
In the vast majority of cases it displays an error message (error 4 or error 8) and no test result is displayed. In rare cases, a falsely elevated test result might be displayed (with or without an error message).
Cleaning with certain cleaning agents has been identified as the root cause, especially if applied near the test strip guide cover (see picture). Liquid entering the meter can cause damage to the meter.
Effect on Results________________________________________________________________________________
There is a remote risk for falsely elevated results. Please consult with your physician if you have questions about your PT/INR results.
Updated Meter Cleaning Instructions_ ____________________________________________________________
Please follow the procedures below to clean your meter. Failure to follow the procedures may cause malfunction of the device.
Cleaning is only required when the meter is visibly dirty.
n
These updated cleaning procedures replace the current cleaning procedures in your CoaguChek XS user manual.
w
Do not use sprays of any sort!
w
Ensure that the swab or cloth is only damp, not wet!
over...
05920108001
URGENT MEDICAL DEVICE CORRECTION
Roche Diagnostics
Corporation
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250-0457
USA
Tel.+1-800-428-5074
09-112
page 2 of 3
Updated Meter Cleaning Instructions, continued____________________________________________________
Cleaning the Meter Housing (Exterior of Meter):
• Use the cleaning agents listed in the user manual or 91% isopropyl alcohol (“rubbing alcohol”) to clean the meter housing (the exterior of the meter).
• Ensure that the blue test strip guide cover remains tightly closed while cleaning the housing.
• Make sure that no liquid enters the meter or accumulates near any opening.
• Wipe away any remaining moisture and fluids after cleaning the housing.
• Allow wiped areas to dry for at least 15 minutes before performing a test.
Cleaning the Meter Test Strip Guide:
• Use only 91% isopropyl alcohol (“rubbing alcohol”) to clean the test strip guide. No other cleaning solutions are approved for the test strip guide. DO NOT use 70% isopropyl alcohol or 10% bleach solution, including CoaguWipe Bleach Towels.
• Hold the meter upright with the test strip guide facing down.
Correct Incorrect
09-112
page 3 of 3
Updated Meter Cleaning Instructions, continued____________________________________________________
Cleaning the Meter Test Strip Guide, continued:
• Clean the easily accessible areas with a cotton swab. Wipe away remaining moisture and fluids.
• Let the inside of the test strip guide dry for at least 15 minutes before re-attaching the test strip guide cover and testing again.
Please contact Roche Diagnostics Point of Care Technical Service at 1-800-820-0995 if:
• error 4 appears when turning on the instrument the first time after cleaning, or
• error 8 appears during the first measurement after cleaning.
Actions Required________________________________________________________________________________
• Use the cleaning procedures outlined in this UMDC for your CoaguChek XS meter.
• Please contact Roche Diagnostics Point of Care Technical Service at 1-800-820-0995 if:
• error 4 appears when turning on the instrument the first time after cleaning, or
• error 8 appears during the first measurement after cleaning.
• Keep this Urgent Medical Device Correction (UMDC) for future reference.
Questions______________________________________________________________________________________
Please contact Roche Diagnostics Point of Care Technical Service at 1-800-820-0995 if you have
questions about the information contained in this Urgent Medical Device Correction.
This UMDC is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form
3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail to
MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax [1-800-FDA-0178].
COAGUCHEK is a trademark of Roche.
Attention: Patient Self-Testers
CoaguChek XS System — Cleaning-Related Malfunction of Meter with Potential to Impact Results
Issue___________________________________________________________________________________________
Internal investigations have confirmed that recommended cleaning procedures for the CoaguChek XS system can, in rare circumstances, cause a meter malfunction which could lead to falsely elevated results.
In the vast majority of cases it displays an error message (error 4 or error 8) and no test result is displayed. In rare cases, a falsely elevated test result might be displayed (with or without an error message).
Cleaning with certain cleaning agents has been identified as the root cause, especially if applied near the test strip guide cover (see picture). Liquid entering the meter can cause damage to the meter.
Effect on Results________________________________________________________________________________
There is a remote risk for falsely elevated results. Please consult with your physician if you have questions about your PT/INR results.
Updated Meter Cleaning Instructions_ ____________________________________________________________
Please follow the procedures below to clean your meter. Failure to follow the procedures may cause malfunction of the device.
Cleaning is only required when the meter is visibly dirty.
n
These updated cleaning procedures replace the current cleaning procedures in your CoaguChek XS user manual.
w
Do not use sprays of any sort!
w
Ensure that the swab or cloth is only damp, not wet!
over...
05920108001
URGENT MEDICAL DEVICE CORRECTION
Roche Diagnostics
Corporation
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250-0457
USA
Tel.+1-800-428-5074
09-112
page 2 of 3
Updated Meter Cleaning Instructions, continued____________________________________________________
Cleaning the Meter Housing (Exterior of Meter):
• Use the cleaning agents listed in the user manual or 91% isopropyl alcohol (“rubbing alcohol”) to clean the meter housing (the exterior of the meter).
• Ensure that the blue test strip guide cover remains tightly closed while cleaning the housing.
• Make sure that no liquid enters the meter or accumulates near any opening.
• Wipe away any remaining moisture and fluids after cleaning the housing.
• Allow wiped areas to dry for at least 15 minutes before performing a test.
Cleaning the Meter Test Strip Guide:
• Use only 91% isopropyl alcohol (“rubbing alcohol”) to clean the test strip guide. No other cleaning solutions are approved for the test strip guide. DO NOT use 70% isopropyl alcohol or 10% bleach solution, including CoaguWipe Bleach Towels.
• Hold the meter upright with the test strip guide facing down.
Correct Incorrect
09-112
page 3 of 3
Updated Meter Cleaning Instructions, continued____________________________________________________
Cleaning the Meter Test Strip Guide, continued:
• Clean the easily accessible areas with a cotton swab. Wipe away remaining moisture and fluids.
• Let the inside of the test strip guide dry for at least 15 minutes before re-attaching the test strip guide cover and testing again.
Please contact Roche Diagnostics Point of Care Technical Service at 1-800-820-0995 if:
• error 4 appears when turning on the instrument the first time after cleaning, or
• error 8 appears during the first measurement after cleaning.
Actions Required________________________________________________________________________________
• Use the cleaning procedures outlined in this UMDC for your CoaguChek XS meter.
• Please contact Roche Diagnostics Point of Care Technical Service at 1-800-820-0995 if:
• error 4 appears when turning on the instrument the first time after cleaning, or
• error 8 appears during the first measurement after cleaning.
• Keep this Urgent Medical Device Correction (UMDC) for future reference.
Questions______________________________________________________________________________________
Please contact Roche Diagnostics Point of Care Technical Service at 1-800-820-0995 if you have
questions about the information contained in this Urgent Medical Device Correction.
This UMDC is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form
3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail to
MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax [1-800-FDA-0178].
COAGUCHEK is a trademark of Roche.
