BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1761176 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06316
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 14, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THAT CUSTOMER OBTAINED RESULTS OF 80MG/DL, AND 140MG/DL ON ACCU-CHEK AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON THE READINGS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 300412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA AVANDIA/MET 1000MG/DAY - 6 MTHS| GLYBURIDE 2MG/DAY - "NO LONGER TAKING"