BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1002114 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01735
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE VALUE OF 164 MG/DL BACK TO BACK WITH A RESULT OF 83 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYS. REPORTER STATED THAT AT A DIFFERENT TIME ANOTHER COMPARATIVE TEST OF 109 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 61 MG/DL WITHIN 10 MINUTES ON THE SAME SYS. REPORTER INDICATED SHE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF THE SECOND GROUP OF COMPARISON TESTING. REPORTER STATED THAT SHE SELF-TREATED WITH CANDY. 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 PROD 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 300930

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR TARKA - FEW MONTHS| DIOVAN - 1 MONTH| NOVOLOG - 3 DAYS| LIPITOR - FEW MONTHS