BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® AVIVA TEST STRIPS

    MDR report key: 1904303 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06901
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 10, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 302758, EXPIRATION DATE 12/31/2011). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 801 MG/DL AND 801 MG/DL ON AVIVA SYSTEM 1 AND RESULT OF 104 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. THE RESULTS OF 801 MG/DL ARE OUTSIDE THE NUMERIC RANGE OF 10-600 MG/DL OF THE DEVICE. 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 302758

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR NEBULIZER| LANTUS ONCE DAILY| HUMALOG