BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1002646 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01362
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED A BLOOD GLUCOSE RESULT OF 35 MG/DL ON THE ACCU-CHEK COMPACT PLUS METER. THE COMPACT PLUS METER MEMORY REPORTEDLY RECORDED THE BLOOD GLUCOSE RESULT AS 85 MG/DL. THE REPORTER ALSO OBTAINED A BLOOD GLUCOSE RESULT OF 172MG/DL ON THE ACCU-CHEK COMPACT PLUS METER AND THE METER MEMORY REPORTEDLY RECORDED THE BLOOD GLUCOSE RESULT AS 97MG/DL. NO REPORTED ACTIONS TAKEN BASED ON THE EVENT. 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 PLUS BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR LIPITOR 20MG/DAY| PAROXETINE 10MG/DAY| PLAVIX 75MG/DAY| ISOSORBIDE MONONITRATE 30MG/D| LISINOPRIL 10MG/DAY| ASPIRIN 81MG/DAY| DIABETA 125MG/DAY| CORETCR 40MG/DAY| PAPAVERINE 150MG/DAY