BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1051715 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04120
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED METER RESULTS OF 189 MG/DL, 240 MG/DL, 345 MG/DL, AND 500 MG/DL WITHIN 10 MINS ON THE AVIVA SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS CORP. 300835

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HUMULIN 50 UNITS/DAY