BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1082542 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05716
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE TESTED THE 5-YEAR-OLD CUSTOMER AND OBTAINED THE BLOOD GLUCOSE COMPARISON OF 500MG/DL AND 26MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10-MINUTES TIMEFRAME. SHE STATES THAT SHE GAVE THE CUSTOMER EXTRA INSULIN BASED ON SOME OF THE CUSTOMER'S RESULTS. SHE WAS NOT SPECIFIC WHICH RESULTS SHE TREATED. THE CUSTOMER DID NOT RECEIVE MEDICAL INTERVENTION. NEW SYSTEM SENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR LANTUS - 4 MONTHS| NOVOLOG - 4 MONTHS