BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2519313 · Received April 6, 2012

    Report

    Report Number
    2531779-2012-02885
    Event Type
    Death
    Date Received
    April 6, 2012
    Date of Event
    November 3, 2010
    Report Date
    March 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE WHEREABOUTS OF THE PUMP ARE UNKNOWN AT THIS TIME. 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 REPORTER CALLED ANIMAS IN RESPONSE TO MAIL ADDRESSED TO THE PATIENT AND REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2010. THE REPORTER ASKED THAT THE PATIENT'S NAME BE REMOVED FROM THE MAILING LIST. THE REPORTER STATED THAT THE PATIENT WAS FOUND UNCONSCIOUS AT A RESIDENCE WHICH SHE OCCUPIED AS A HOUSE-SITTER, EMERGENCY SERVICES WAS SUMMONED, AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT WAS USING THE PUMP AT THE TIME OF DEATH. THE REPORTER NOTED THAT THE PUMP WAS TAKEN AWAY AND NEVER RETURNED. THE CAUSE OF DEATH WAS SAID TO BE DIABETIC KETOACIDOSIS (DKA) AND CARDIAC ARREST. A FAMILY MEMBER DID NOT IMPLICATE THAT THE PUMP WAS RELATED TO THE PATIENT'S DEATH. THE PATIENT'S FILE INDICATES THAT SHE FIRST BEGAN USE OF AN ANIMAS PUMP IN 2005; NO COMPLAINTS WERE MADE AGAINST THE PUMP WORN AT THE TIME OF DEATH WHICH WAS FIRST USED BY THE PATIENT AROUND (B)(6) 2009. ALTHOUGH THERE IS NO ALLEGATION THAT THE PUMP WAS RELATED TO THE PATIENT'S DEATH, THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED DKA DURING USE OF THE INSULIN PUMP AND SUBSEQUENTLY DIED. THERE ARE NO DETAILS AVAILABLE ABOUT THE SEQUENCE OF EVENTS THAT CONTRIBUTED TO THE HYPERGLYCEMIA AS THE PATIENT WAS ALONE PRIOR TO AND AT THE TIME OF DEATH. THEREFORE, THE USE OF THE INSULIN PUMP CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE PATIENT'S DEMISE.

    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 48 YR Death