BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2833777 · Received November 15, 2012

    Report

    Report Number
    2531779-2012-13651
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 19, 2012
    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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE DOWN ARROW KEYPAD BUTTON IS UNRESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION REMAINED UNRESOLVED. THERE IS NO INDICATION THAT THE ALLEGED ISSUE CONTRIBUTED TO AN ADVERSE EVENT.

    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