BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1715998 · Received June 8, 2010

    Report

    Report Number
    2531779-2010-00355
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    May 8, 2010
    Report Date
    May 11, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. 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. IT WAS REPORTED THAT THE PT COMPLETED INSULIN PUMP TRAINING WITH A HOSPITAL CERTIFIED DIABETES EDUCATOR APPROXIMATELY ONE WEEK PRIOR TO THE EVENT. PER THE PT'S CDE, ANECDOTAL INFO HAD BEEN PROVIDED THAT THE PT HAD A HISTORY OF OVER ADMINISTRATION OF INSULIN AND HYPOGLYCEMIA PRIOR TO INITIATION OF IPT. 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 PASSED AWAY FOLLOWING A HYPOGLYCEMIC EVENT AND CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death