BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2618244 · Received June 15, 2012

    Report

    Report Number
    2531779-2012-05316
    Event Type
    Death
    Date Received
    June 15, 2012
    Date of Event
    February 12, 2012
    Report Date
    May 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE REPORTER AGREED TO RETURN THE PUMP FOR INVESTIGATION. 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, IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2012 OF SELF-INFLICTED GUNSHOT WOUNDS. THE REPORTER STATED THAT HE WAS WEARING THE PUMP AT THE TIME OF HIS DEATH; BLOOD GLUCOSE LEVELS (BG) AT THAT TIME WERE NOT AVAILABLE. IT WAS REPORTED THAT THE PATIENT'S BLOOD ALCOHOL LEVEL WAS HIGH AT THE TIME OF DEATH. NO OTHER DETAILS COULD BE OBTAINED REGARDING THE SEQUENCE OF EVENTS LEADING UP TO THE PATIENT'S DEMISE. THE REPORTER MENTIONED THAT THE PATIENT'S BG HAD BEEN HIGHER THAN USUAL (120 - 180MG/DL) DURING THE WEEKS PRIOR TO HIS DEATH. IT WAS ALLEGED THAT THE PATIENT HAD NON-SPECIFIC ISSUES WITH THE CARTRIDGES AND HAD CONSIDERED GETTING A NEW PUMP. THE REPORTER STATED THAT SHE WAS UNSURE WHAT ISSUES, IF ANY, HE WAS HAVING WITH THE PUMP AND DID NOT KNOW IF INSULIN WAS DELIVERED WHEN BG WAS ELEVATED. ANIMAS HAS NO COMPLAINTS OR CONTACTS ON RECORD REGARDING THESE SECOND-HAND COMPLAINTS. SEVERAL WEEKS PRIOR TO THE PATIENT'S DEATH, THE PATIENT WAS REPORTEDLY STOPPED BY POLICE FOR RECKLESS DRIVING. THE DATE OF THE INCIDENT COULD NOT BE CONFIRMED. THE REPORTER STATED THAT EMERGENCY MEDICAL SERVICES WERE CALLED AND THE PATIENT'S BG WAS REPORTED TO BE AROUND 300MG/DL. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: ALTHOUGH, THE OFFICIAL CAUSE OF DEATH WAS SAID TO BE SELF-INFLICTED GUNSHOT WOUNDS, IT IS UNCERTAIN IF A BLOOD GLUCOSE ELEVATION OCCURRED AROUND THE SAME TIME. THERE ARE ALLEGATIONS THAT AN UNNAMED DEVICE MALFUNCTION MAY HAVE CAUSED OR CONTRIBUTED TO ELEVATED BLOOD GLUCOSE LEVELS DURING THE WEEKS PRIOR TO THE PATIENT'S DEATH.

    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 39 YR Death