BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2518368 · Received April 5, 2012

    Report

    Report Number
    2531779-2012-02834
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 6, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX WAS REVIEWED FROM (B)(4) 2012, WITH NO EVIDENCE OF DELIVERY INTERRUPTIONS OR MALFUNCTIONS. THE TOTAL DAILY DOSE BASAL DELIVERIES WERE REVIEWED AND WERE FOUND TO BE CONSISTENT WITH THE ACTIVE BASAL PROGRAM. THE LAST BASAL DELIVERY WAS RECORDED ON (B)(6) 2012 AT 6:36 AM, FOLLOWED BY AN AUTOOFF ALARM AT 6:39 AM; NO DELIVERIES WERE RECORDED AFTER THE AUTO OFF. THE LAST 5 BOLUSES RECORDED ON THE PUMP WERE FROM (B)(6) 2012 BETWEEN 12:23 AM AND 2:35 PM. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO PUMP DELIVERY RELATED DEFECTS WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD AT HOME ON (B)(6) 2012. THE PATIENT WAS SAID TO BE WEARING THE PUMP AT THE TIME OF DEATH BUT DETAILS ABOUT THE PUMP HISTORY CANNOT BE DETERMINED. A SECOND REPORTER REFUSED TO REVIEW THE PUMP WITH CUSTOMER TECHNICAL SUPPORT. THE SECOND REPORTER SPOKE TO THE PATIENT ON (B)(6) 2012, AND THE PATIENT SAID THAT SHE FELT UNWELL; THE REPORTER WAS UNABLE TO PROVIDE DETAILS OF THE ILLNESS, THE BLOOD GLUCOSE VALUES, OR THE SEQUENCE OF EVENTS LEADING UP TO THE DEATH. IT WAS NOTED THAT THE CAUSE OF DEATH WAS UNKNOWN AND THE AUTOPSY AND TOXICOLOGY REPORTS WERE NOT YET AVAILABLE. THIS INCIDENT IS BEING REPORTED BECAUSE THE PATIENT WAS ATTACHED TO THE INSULIN PUMP AT THE TIME OF DEATH AND THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME.

    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 43 YR Death