BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1181680 · Received September 30, 2008

    Report

    Report Number
    1823260-2008-07264
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 25, 2007
    Report Date
    September 30, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE AVIVA SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, AND 120 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT SYSTEM 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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HUMULIN R| HUMULIN NPH