BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2528780 · Received April 11, 2012

    Report

    Report Number
    2531779-2012-03065
    Event Type
    Death
    Date Received
    April 11, 2012
    Date of Event
    December 6, 2011
    Report Date
    March 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCATION OF THE PUMP HAS NOT BEEN ESTABLISHED. THE REPORTER IS UNAWARE OF WHERE THE PUMP MIGHT BE AND THE CORONER'S OFFICE IS NOT IN POSSESSION OF THE PUMP. THEREFORE, 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, A FAMILY MEMBER CALLED TO OBTAIN ASSISTANCE WITH QUESTIONS ABOUT A BILL. DURING THE CALL, IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2011. THE REPORTER SAID THAT THE PATIENT WAS FOUND BY A THIRD PARTY WHO RECALLED TO HIM THE FOLLOWING SEQUENCE OF EVENTS: THE PATIENT APPARENTLY HAD BEEN SICK WITH THE FLU. AT THE TIME OF DEATH, THE PATIENT WAS REMOVED FROM THE PUMP AND WAS IN THE PROCESS OF REPLACING THE INFUSION SET. THE PATIENT ALLEGEDLY DROPPED OVER AND DIED. IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS 400MG/DL OR SO. EMERGENCY MEDICAL TECHNICIANS WERE SUMMONED BUT WERE UNABLE TO REVIVE THE PATIENT. THE PATIENT RECEIVED THE PUMP IN (B)(6) 2009 AND THERE HAVE BEEN NO COMPLAINTS AGAINST THE PUMP AND NO REPORTED ADVERSE EVENTS ASSOCIATED WITH THE PUMP. THIS COMPLAINT IS BEING REPORTED BASED ON THE POSSIBILITY THAT A BLOOD GLUCOSE EXCURSION MAY BE RELATED TO THE CAUSE OF DEATH AND THE CHANCE THAT THE USE OF AN INSULIN PUMP, MALFUNCTION OR MISUSE MAY HAVE BEEN RELATED TO THE BLOOD GLUCOSE EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death