BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1971857 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00483
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 40 MG/DL ON AVIVA SYSTEM 1, 101 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 302956

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR INSULIN PUMP| HUMALOG