BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1060074 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04687
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 168MG/DL AND 95MG/DL ON THE ACCU-CHEK COMPACT PLUS SYSTEM WITHIN A TEN MINUTE TIMEFRAME. NO ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 20670241

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LANTUS 90 UNITS/DAY| METFORMIN 2000MG/DAY