BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1915150 · Received December 6, 2010

    Report

    Report Number
    1823260-2010-07163
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    September 19, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 454 MG/DL (AVIVA) AND 201 MG/DL (FRIEND'S ACCU-CHEK METER, TYPE UNKNOWN) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. INFORMATION FOR FRIEND'S METER WAS UNAVAILABLE AT THE TIME OF THE CALL. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NOVOLOG 70/30 FLEX PEN 3X DAILY