BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1973014 · Received January 20, 2011

    Report

    Report Number
    2531779-2011-00356
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Report Date
    December 21, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR, THE PT STATED THAT THE PUMP WAS NOT PROPERLY DELIVERING THE BASAL INSULIN AS PROGRAMMED IN THE PUMP. THE PT'S BLOOD GLUCOSE (BG) ON (B)(6) 2010 WAS REPORTEDLY 120 MG/DL. THE NEXT MORNING THE PT'S BG WAS 450 MG/DL. THE INFUSION SET WAS REPORTEDLY NOT BENT AND THE PT CHANGES THE INFUSION SITE EVERY 3 DAYS. THERE WERE NO ALARMS IN THE HISTORY AND THE PT WAS NOT REUSING CARTRIDGES. THE PT DENIED SEEKING MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1