BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2050428 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02264
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING TESTING, PUMP WAS LOADED AND PRIMED SUCCESSFULLY. DURING EVALUATION, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    PUMP IS RETURNED FOR A SHORT LOAD STEP CAUSING A LARGE PRIME VOLUME. EVALUATION REVEALED OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS BEING MADE BASED 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 ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1