BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1011754 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02334
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CALLER DID NOT KNOW WHICH LOT PRODUCED SPECIFIC RESULTS. SEE MEDWATCHES WITH A1 PT FOR POSSIBLE SYSTEMS INVOLVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS HER FRIEND OBTAINED RESULTS OF 55 MG/DL, 44 MG/DL, 60 MG/DL, 135 MG/DL, AND 189 MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. FRIEND DRANK SODA DUE TO SYMPTOMS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, SYSTEM WILL NOT BE RETURNED.

    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 300604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOVOLOG| LEVEMIR