BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1942026 · Received December 30, 2010

    Report

    Report Number
    1823260-2010-07755
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 19, 2010
    Report Date
    January 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE AVIVA METER 535. (B)(6).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 55 MG/DL (AVIVA 525) AND 110 MG/DL (AVIVA 535) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REVIEW OF STORAGE, HANDLING, DOSING, AND TECHNIQUE WAS PERFORMED # CUSTOMER DOES NOT ALWAYS WASH HANDS PRIOR TO TESTING. 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 302500

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR BYETTA| GLYBURIDE