BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1897193 · Received November 8, 2010

    Report

    Report Number
    2531779-2010-02120
    Event Type
    Death
    Date Received
    November 8, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DIED SOMETIME DURING HIS SLEEP BETWEEN THE EVENING OF (B)(6) 2010 AND THE MORNING OF (B)(6) 2010. ACCORDING TO HIS SPOUSE, HE WAS WEARING HIS PUMP AT THE TIME OF HIS DEATH; HIS LAST BOLUS WAS ON THE EVENING OF (B)(6) 2010. THE DIABETES SPECIALIST NURSE REPORTED THAT SHE TRAINED HIM EXTENSIVELY ON THE PUMP BEGINNING IN (B)(6) 2010, THE PT WAS DOING VERY WELL ON THE PUMP, AND THERE WERE NO REPORTS OF BLOOD GLUCOSE EXCURSIONS OR PUMP MALFUNCTIONS. AT THIS TIME, THERE IS NO CONFIRMATION OF INSULIN DELIVERY OR BLOOD GLUCOSE READINGS IMMEDIATELY PRIOR TO HIS DEATH. THE CONFIRMED CAUSE OF DEATH FROM THE CORONER'S OFFICE WAS MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death