BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2893609 · Received January 2, 2013

    Report

    Report Number
    2531779-2013-00082
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE INSULIN ON BOARD (IOB) CALCULATION APPEARED TO BE INCORRECT. THE PATIENT REPORTED THAT AN EZCARB BOLUS WAS DELIVERED FOR BREAKFAST IN THE MORNING. THE PATIENT INDICATED THAT AT LUNCH TIME, GREATER THAN FOUR HOURS LATER, THE PUMP STILL INDICATED INSULIN IN THE IOB. THE PUMP SETTINGS WERE REVIEWED AND CONFIRMED THAT THE IOB WAS TURNED ON WITH A DURATION OF 4 HOURS. THE BOLUS HISTORY WAS REVIEWED AND FOUND THAT THE LAST BOLUS WAS 11:03 AM, AT 3:33 PM THE PUMP INDICATED 1.26 UNITS STILL REMAINING IN THE IOB. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE IOB CALCULATION ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR