BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1063790 · Received June 19, 2008

    Report

    Report Number
    1823260-2008-04866
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 31, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 92 MG/DL, 286 MG/DL, 188 MG/DL AND 208 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. 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 COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 206771

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR GLYBURIDE - 5 MG ONCE DAILY - ABOUT ONE YEAR| "MONOXIN" - 0.125 MG ONCE DAILY| PLAVIX - 75MMG ONCE DAILY| "AVANDAR" - 0.5 MG ONCE DAILY