BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1063590 · Received June 20, 2008

    Report

    Report Number
    1823260-2008-04880
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE VALUE OF 150 MG/DL BACK TO BACK WITH A RESULT OF 470 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINS ON THE VOICEMATE ADVANTAGE SYSTEM. REPORTER STATED THAT AT A DIFFERENT TIME ANOTHER TEST OF 92 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 22 MG/DL WITHIN 10 MINS ON THE SAME SYSTEM. REPORTER STATED THAT AT A DIFFERENT TIME OTHER TESTS OF 214 MG/DL AND 14 MG/DL WERE PERFORMED BACK TO BACK WITH A RESULT OF 29 MG/DL WITHIN 10 MINS ON THE SAME SYSTEM. WITHIN 10 MINS OF THE LAST 3 READINGS, ANOTHER RESULT OF 288 MG/DL WAS OBTAINED ON THE SAME SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE, AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR CHOLESTEROL MEDICATIONS| ASTHMA CORT - AS NEEDED| HORMONE MEDICATIONS| GLYBURIDE - SEVERAL YRS| XANAX| AVANDIA - SEVERAL YRS| MAXAIR| THEOPHYLLINE-SEVERAL YRS - 300MG TWICE DAILY| VERAPAMIL - 120MG TWICE DAILY| PRILOSEC - 20MG TWICE DAILY| ZOLOFT - 150MG "ONCE"| GLUCOPHAGE/METFORMIN - SEVERAL YRS-1000MG "TWICE"