BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1181582 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07175
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 70 MG/DL BACK TO BACK WITH A RESULT OF 247 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND THE CUSTOMER DECLINED THE REPLACEMENT PRODUCT BEING 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 301213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HUMALOG| LANTUS - 28 UNITS DAILY