BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1903743 · Received November 20, 2010

    Report

    Report Number
    1823260-2010-06880
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    November 16, 2010
    Report Date
    January 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 308 MG/DL, 138 MG/DL, 167 MG/DL, AND 126 MG/DL. CUSTOMER STATES THE TEST STRIP WAS NOT COMPLETELY FILLED WHEN HE TESTED 308 MG/DL AND HE HAD ATTEMPTED TO REFILL IT. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT 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 ROCHE DIAGNOSTICS NA 302688

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR