BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1771246 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01577
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULTS OF 474 MG/DL BACK TO BACK WITH A RESULTS OF 222 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS EXPERIENCING SOME 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 REPLACEMENT PRODUCT WAS SENT. REPORTER STATED THAT SHE POSSIBLY DISCARDED THE STRIP VIAL AND SO IT IS POSSIBLE THAT NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR LOPID - 650MG TWICE DAILY| LAMICTAL - 300MG ONCE DAILY| LEVEMIR - 10 UNITS ONCE DAILY| REMERON - 30MG ONCE DAILY| CLONIDINE - 0.10MG ONCE DAILY| EFFEXOR - 100MG 3 TIMES DAILY| GLUCOPHAGE - 250MG TWICE DAILY| TRAZODONE - 300MG ONCE DAILY| LEVOTHYROXINE - 0.10MG ONCE DAILY