BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1012775 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02359
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 333 MG/DL, 232 MG/DL, 163 MG/DL, 147 MG/DL, 213 MG/DL, 193 MG/DL AND 326 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER INDICATED THAT HE WAS EXPERIENCING SOME HYPOGLYCEMIC 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300883

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR LANTUS - 10 YEARS| HUMULIN R - 10 YEARS