BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2518515 · Received April 5, 2012

    Report

    Report Number
    2531779-2012-02844
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    August 16, 2009
    Report Date
    March 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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)(6) 2012 REPORTING THAT THE PATIENT HAD PASSED; NO OTHER INFORMATION WAS PROVIDED. ACCORDING TO THE PATIENT'S OBITUARY, THE PATIENT HAD PASSED AWAY SUDDENLY ON (B)(6) 2009. THERE IS NO ALLEGATION OR EVIDENCE THAT THE PATIENT'S DEATH WAS RELATED TO DIABETES. FURTHER INFORMATION ABOUT THE PATIENT'S DEATH WAS NOT AVAILABLE. THIS REPORT IS MADE BECAUSE THERE IS NOT ENOUGH INFORMATION AVAILABLE TO RULE OUT THE PUMP 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 74 YR Death