BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2921412 · Received January 17, 2013

    Report

    Report Number
    2531779-2013-00808
    Event Type
    Death
    Date Received
    January 17, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(4) 2012 STATING THAT THE PATIENT PASSED AWAY ON (B)(6) 2012. ADDITIONAL INFORMATION WAS NOT PROVIDED AT THE TIME OF INITIAL CONTACT. THE REPORTER FOLLOWED UP WITH ANIMAS CUSTOMER TECHNICAL SUPPORT ON (B)(6) 2013 AND PROVIDED ADDITIONAL INFORMATION. THE REPORTER STATED THAT THERE WAS NO AUTOPSY PERFORMED AND AN AUTOPSY IS NOT EXPECTED. THE REPORTER STATED THAT THE DEATH WAS UNEXPECTED AND SHE BELIEVED THE PATIENT'S DEATH WAS CAUSED BY EMBOLISM. THE REPORTER STATED THAT THE CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS CHRONIC RENAL INSUFFICIENCY, ASTHMA AND TYPE I DIABETES MELLITUS. THE REPORTER STATED THAT THE PATIENT STOPPED USING THE PUMP AROUND (B)(6) 2012 BECAUSE HE BELIEVED THE PUMP WAS NOT WORKING WELL. THE REPORTER DID NOT PROVIDE DETAILS OF WHY THE PATIENT BELIEVED THE PUMP WAS NOT WORKING WELL. THE REPORTER STATED THAT THE PUMP WAS NOT IMPLICATED IN THE CAUSE OF DEATH AND THERE WAS NO BLOOD GLUCOSE (BG) VALUE PROVIDED. THE REPORTER NOTED THAT THE PATIENT WAS NOT TESTING HIS BG. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE SEQUENCE OF EVENTS LEADING UP TO THE PATIENT'S DEATH. THIS COMPLAINT IS BEING REPORTED BECAUSE DIABETES WAS LISTED ON THE DEATH CERTIFICATE AS A CONTRIBUTING FACTOR IN THE PATIENT¿S DEATH AND BECAUSE THE PUMP COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR IN THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25931 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death