BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® AVIVA TEST STRIPS

    MDR report key: 1904652 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06852
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 12, 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
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 477 MG/DL ON THE AVIVA SYSTEM AND 227 MG/DL ON PROFESSIONAL DEVICE WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST STRIPS; 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 302312

    Patients

    Seq Age Sex Outcome Treatment
    1 077 YR METFORMIN| GLIPIZIDE