BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 1770715 · Received September 5, 2007

    Report

    Report Number
    1823260-2007-07778
    Event Type
    Malfunction
    Date Received
    September 5, 2007
    Date of Event
    August 22, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE BLOOD GLUCOSE MONITORING ACTIVE SYSTEM GENERATED A RESULT OF LO (LESS THAN 10 MG/DL) WHEN A NEW TEST STRIP WAS INSERTED INTO THE SYSTEM PRIOR TO IT BEING DOSED WITH BLOOD OR CONTROL SOLUTION. 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 ACTIVE BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR COREG - 1-2 YRS - 3.125MG TWICE DAILY| LISINOPRIL - 6YRS - 10MG ONCE DAILY| DUMESTAT - 6 YRS - 1000MG TWICE DAILY| LIPITOR - 6 YRS - 40MG ONCE DAILY