BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUC-CHEK AVIVA TEST STRIPS

    MDR report key: 818738 · Received January 11, 2007

    Report

    Report Number
    1823260-2007-00340
    Event Type
    Malfunction
    Date Received
    January 11, 2007
    Date of Event
    December 27, 2006
    Report Date
    January 11, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    k060620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE DEVICE MEASURED 254, 105, & 127 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES. AS A RESULT OF THE COMPARISON, NO ACTIONS WERE TAKEN OR TREATMENT WAS RECEIVED REPORTEDLY AS A RESULT. 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 ACCUC-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS -LFR LFR ROCHE DIAGNOSTICS * 300403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA