BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2071784 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02953
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATE 05/2007. 2531779-03/24/2010-003-R. PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED AN OUT OF CALIBRATION FORCE SENSOR.

    Description of Event or Problem · 1

    PUMP WAS RETURNED TO ANIMAS FOR A SHORT LOAD STEP CAUSING A LARGE PRIME VOLUME. INVESTIGATION REVEALED AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS BEING MADE ON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 51