BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1770548 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09205
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED CUSTOMER OBTAINED BLOOD GLUCOSE RESULTS OF 150 MG/DL AND 87 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE ACTIVE S SYSTEM. NO SYMPTOMS WERE REPORTED. CUSTOMER DID NOT TREAT OR ACT ON THE RESULTS. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. A REQUEST WAS MADE FOR THE RETURN OF THS SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22963734

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK METFORMIN - 1,000 MG DAILY| SIMVASTATIN - 40MG DAILY| ATENOLOL - 75 MG DAILY| HCTZ - 25MG DAILY| FOSINOPRIL - 80 MG DAILY