BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1336775 · Received March 10, 2009

    Report

    Report Number
    1823260-2007-05173
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Date of Event
    May 30, 2007
    Report Date
    June 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 152, 132, & 82 MG/DL WHEN TESTING WAS PERFORMED ON THE COMPACT PLUS SYSTEM AT 6.37 PM. NO EXACT TIMEFRAME BETWEEN TESTS WAS REPORTED OTHER THAN THE REFERENCE BACK TO BACK. REPORTER STATED SELF TREATING WITH ORANGE JUICE AND FOOD HOWEVER NO OTHER ACTIONS OR TREATMMENT 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 ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NOVOLOG 70/30 26UN TWICE DAILY