BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1002651 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01370
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT SYSTEM WITH RESULTS OF 205 MG/DL. NO QUALITY CONTROL INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20671241

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR "RELI-ON" 70-30 54 UNITS PM - 16 YEARS| TRAMADOL 50 MG 2X/DAY - 3 YEARS| LOVASTATIN 20MG 2X/DAY - 3 YEARS| LASIX 20MG/DAY - 3 YEARS| VALTREX 2.5MG/DAY - 3 YEARS| "RELI-ON" 70-30 22 UNITS AM - 16 YEARS| BABY ASPIRIN| ZOLOFT 100 MG/DAY - 1 YEAR| PRILOSEC 20 MG/DAY - 3 YEARS| METOPROLOL 50 MG - 3 YEARS| FOLIC ACID 1 MG/DAY - 9 MONTHS