BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2518514 · Received April 5, 2012

    Report

    Report Number
    2531779-2012-02846
    Event Type
    Death
    Date Received
    April 5, 2012
    Report Date
    March 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). A COPY OF THE PATIENT'S DEATH CERTIFICATE WAS RECEIVED BY ANIMAS ON (B)(4) 2012 LISTING THE PATIENT'S CAUSE OF DEATH AS "SEIZURE DISORDER" AND MANNER OF DEATH LISTED AS "NATURAL". DIABETES WAS NOT INDICATED AS A CAUSE OR CONTRIBUTING FACTOR TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A REPORTER CONTACTED ANIMAS SALES DEPARTMENT TO REPORT THAT THE PATIENT HAD PASSED AWAY BUT WAS UNWILLING OR UNABLE TO PROVIDE ADDITIONAL INFORMATION. MULTIPLE ATTEMPTS TO REACH THE PATIENT'S FAMILY MEMBERS AND HEALTH CARE PROVIDERS FOR OTHER INFORMATION WERE UNSUCCESSFUL. THERE IS NO ALLEGATION OR INDICATION THAT THE PATIENT'S DEATH WAS RELATED TO DIABETES OR TO THE USE OF THE PUMP. HOWEVER, THIS REPORT IS MADE BECAUSE OF THE POSSIBILITY THAT THE PATIENT'S DEATH WAS RELATED TO THE USE OF AN INSULIN PUMP, MALFUNCTION OR MISUSE.

    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 36 YR Death