BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3214048 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-10055
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    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. 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2013, WITH BLOOD GLUCOSE LEVELS OVER 600 MG/DL WITH SEVERE SYMPTOMS OF CONFUSION, AGITATION, AND PARANOIA. A REVIEW OF THE PUMP HISTORY RELATED TO THIS EVENT INDICATED THAT THE PATIENT HAD NOT BOLUSED SINCE (B)(6) 2013. THE PUMP HISTORY ALSO SHOWED TWO SUSPEND EVENTS ON (B)(6) 2013, AT 8:29 PM, RESUMED AT 9:03 PM AND 8:29PM, RESUMED IMMEDIATELY AT 8:29 PM. THE REPORTER INDICATED THAT THE PATIENT HAD DISCONTINUED USE OF THE PUMP IN FAVOR OF INJECTIONS AND INDICATED THAT THE PATIENT WAS NO LONGER ABLE TO OPERATE THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313650 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L