BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 1780601 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08470
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 6, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED WHEN LOOKING IN THE COMPACT SYSTEM MEMORY; SHE COULD NOT RECALL OBTAINING THE RESULT OF 578 MG/DL RESULT; HOWEVER, IT WAS COMPARED TO A READING OF 218 MG/DL THAT HAD BEEN PERFORMED 9 MINUTES APART. REPORTER STATED SHE DID RECALL RECEIVING THE RESULT OF 218 MG/DL; HOWEVER, NO ACTIONS WERE REPORTED TAKEN OR TREATMENT 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 BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR PRANDIN - 6MOS, 2PILLS TWICE DAILY| ACTOS - 6 MOS, 1PILL ONCE DAILY