BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2517940 · Received April 5, 2012

    Report

    Report Number
    2531779-2012-02822
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    January 15, 2012
    Report Date
    March 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS IN RESPONSE TO AN ANIMAS MAILING AND STATED THAT THE PATIENT HAD DIED AT HOME ON (B)(6) 2012. THE REPORTER STATED THAT THE CAUSE OF DEATH WAS CARCINOID TUMORS, AND THAT THE PATIENT WAS USING THE PUMP FOR SANDOSTATIN. THE REPORTER DID NOT IMPLICATE THE PUMP IN THE PATIENT'S DEATH, AND STATED THAT THE PUMP HAD BEEN DONATED TO A LOCAL PHARMACY. THIS INCIDENT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: EVEN THOUGH THE PATIENT'S CAUSE OF DEATH WAS UNRELATED TO DIABETES, THE PATIENT WAS KNOWN TO HAVE USED THE INSULIN PUMP TO DELIVER A DRUG THAT IS NOT APPROVED FOR USE IN THIS DEVICE.

    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 61 YR Death