BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 1770961 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09890
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED, BLOOD GLUCOSE RESULT OF LO (LESS THAN 10 MG/DL) IMMEDIATELY AFTER THE UNDOSED TEST STRIP WAS PLACED IN THE ACTIVE METER. NO ACTIONS WERE REPORTED TAKEN OR TREATMENTS RECEIVED. NO ADVERSE EVENT 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 ACTIVE BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR VITAMIN B12 - 5 YEARS - DOSAGE UNK ONCE DAILY| LIPITOR - 5 YEARS - 20MG ONCE DAILY| BABY ASPIRIN - 2 MONTHS - 81MG ONCE DAILY| VITAMIN B6 - 5 YEARS - 1000 IU ONCE DAILY| COZAAR - 2-3 YEARS - 100MG ONCE DAILY| METOPROLOL - 5 YEARS - 50MG 1/2 TAB ONCE DAILY| AMLODIPINE - 5 YEARS - 10MG ONCE DAILY| VITAMIN D - 5 YEARS - DOSAGE UNK ONCE DAILY| HUMULIN N - 15 YEARS - 10 UNITS DAILY| HUMULIN R - 15 YEARS - 57 UNITS DAILY| GARLIC SUPPLEMENT - 5 YEARS - 1000MG TWICE DAILY