BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1200129 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07631
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 100 MG/DL BACK TO BACK WITH A RESULT OF 483 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT SHE WAS EXPERIENCING SOME HYPERGLYCEMIC SYMPTOMS PRIOR TO TESTING AND HER HUSBAND CALLED 911 AFTER THE RESULTS WERE OBTAINED. REPORTER STATED THE PARAMEDICS OBTAINED A RESULT OF 129 MG/DL ON THEIR SYSTEM AND TOOK HER TO THE HOSPITAL WHERE A 183 MG/DL RESULT WAS OBTAINED. REPORTER STATED SHE WAS GIVEN ORANGE JUICE AT THE HOSPITAL HOURS AFTER SHE ARRIVED. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. 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 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR