BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2323690 · Received November 3, 2011

    Report

    Report Number
    2531779-2011-08222
    Event Type
    Malfunction
    Date Received
    November 3, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. THE PUMP WAS EXERCISED AND THE LOSS OF PRIME WAS NOT DUPLICATED. THIS COMPLAINT IS BEING REPORTED BASED ON PUMP EVALUATION COMPLETED ON 10/7/2011 (B)(6). RECALL #: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    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