BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 820870 · Received January 11, 2007

    Report

    Report Number
    1823260-2007-00289
    Event Type
    Malfunction
    Date Received
    January 11, 2007
    Date of Event
    December 13, 2006
    Report Date
    January 11, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K022171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT HE GETS UNDOSED RESULTS, SUCH AS 103, 118 AND 131 MG/DL WHEN HE PUSHES DOWN ON AN UNDOSED STRIP. NO REPORT OF AN ADVERSE EVENT. CONTROLS WERE NOT RUN. RETURN REQUESTED AND REPLACEMENT WAS SENT.

    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 56 YR LANTUS- 2 WEEKS 15 UNITS 3 TIMES A DAY.| ESGIC- 5YRS 2 TIMES A DAY, DOSAGE| DILANTIN- 30 YRS 50MG 4 TIMES PER DAY.| OXYCONTIN-2YRS 30MG 4 TIMES A DAY.