BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2964047 · Received February 15, 2013

    Report

    Report Number
    2531779-2013-01854
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    March 5, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    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 PASSED AWAY THREE YEARS EARLIER. THE REPORTER INDICATED THAT THE PATIENT WAS A RESIDENT AT A NURSING HOME AT THE TIME OF DEATH AND THE REPORTER WAS UNSURE OF THE PATIENT'S MEDICAL HISTORY. THE REPORTER STATED THAT THE DEATH CERTIFICATE INDICATED A CAUSE OF DEATH OF HEART CONDITION SECONDARY TO DIABETES. THE REPORTER INDICATED THINKING THAT THE PATIENT WAS USING THE PUMP AT THE TIME OF DEATH BUT WAS UNSURE. THE REPORTER CONFIRMED THAT THERE WERE NO KNOWN MALFUNCTIONS OF THE PUMP. THE REPORTER WAS UNSURE WHAT HAPPENED WITH THE PUMP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS MADE BASED ON THE INDICATION THAT PUMP USE COULD NOT BE RULED OUT AS A POSSIBLE CONTRIBUTOR TO THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69228 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death