BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1018228 · Received May 29, 2007

    Report

    Report Number
    1823260-2007-04574
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    May 18, 2007
    Report Date
    May 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K301755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE DEVICE PRODUCED RESULTS OF 471MG/DL TO 187MG/DL WITHIN 10 MINUTES ON THE COMPACT SYSTEM. NO ADVERSE EVENT REPORTED. NO ACTION TAKEN BASED ON DEVICE RESULTS. REQ RETURN OF SUSPECT SYSTEM AND 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 ROCHE DIAGNOSTICS CORP. 20661041

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR