BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3213906 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-10030
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/20/2013 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY DOSE CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES . THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. THE PUMP WAS PRIMED AND EXERCISED FOR 24 HOURS, NO DELIVERY INTERRUPTION OCCURRED DURING THE COURSE OF TESTING. THE PUMP PASSED 29 HOUR FLOW ACCURACY TEST. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF OVER 600 MG/DL WITH CONFUSION AND PARANOIA. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE THE PATIENT WAS TREATED FOR THE HIGH BLOOD GLUCOSE LEVELS WHICH WERE NOT RESOLVING WITH THE PUMP. THE REPORTER INDICATED ISSUES THAT THERE WERE ISSUES WITH THE PUMP AND THE PATIENT NOT GETTING INSULIN. THE PUMP HISTORY WAS REVIEWED AND FOUND THAT THE BOLUS HISTORY WAS INCORRECT. THE REPORTER INDICATED THAT THE HISTORY SHOWED 96.7 UNITS BUT SHOULD HAVE BEEN ONLY 52 UNITS. THE REPORTER ALSO INDICATED THAT THE BASAL RATE SHOULD HAVE SHOWN 11.5 UNITS BUT THE PUMP SHOWED ONLY 9.9 UNITS BASAL DELIVERED. THE REPORTER CONFIRMED THAT THE PATIENT DID NOT PROGRAM A TEMPORARY BASAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313840 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L