BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1051730 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04111
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    February 27, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 216 MG/DL BACK TO BACK WITH A RESULT OF 113 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINS APART. REPORTER STATED HE TOOK HIS PRESCRIBED 500 MG ON JANUMET 45 MINS AFTER OBTAINING THE BACK TO BACK READINGS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. REPORTER STATED HE RAN CONTROLS AND THEY CAME IN RANGE THREE WEEKS PRIOR TO THE BACK TO BACK TESTING. 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 CORP. 300971

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR JANUMET