BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761225 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06400
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 6, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED DISCREPANT BLOOD GLUCOSE RESULTS OF 407 MG/DL BACK TO BACK WITH A RESULT OF 145 MG/DL WHEN TESTING WAS PERFORMED ONE MINUTE APART ON THE COMPACT PLUS SYSTEM. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED RECEIVED. 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 20665642

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR FORTAMET - 1.5YRS, 500MG 1/2 TAB ONCE DAILY| GLIPIZIDE - 1.5YRS, 2.5MG TWICE DAILY| FORTAMET - 1.5YRS, 500MG ONCE DAILY