BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2522025 · Received April 7, 2012

    Report

    Report Number
    2531779-2012-02921
    Event Type
    Death
    Date Received
    April 7, 2012
    Date of Event
    March 21, 2011
    Report Date
    March 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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) DATE OF SUBMISSION (B)(4) 2012 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON APPROPRIATELY TO THE VERIFICATION SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. AN EZPRIME OPERATION WAS PERFORMED WITH NO DIFFICULTIES NOTED, AND THE UNITS REMAINING WERE CORRECTLY CALCULATED AND RECORDED IN THE PUMP HISTORY. A REVIEW OF THE PUMP HISTORY DID NOT FIND ANY ALARMS RELATED TO THE COMPLAINT. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012, REPORTING THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2011. THE REPORTER STATED THAT HE WAS INFORMED THAT THE PATIENT HAD A HEART ATTACK AND DIED OF "NATURAL CAUSES". THE REPORTER CONFIRMED THAT THE PATIENT WAS WEARING THE PUMP AT THE TIME OF DEATH. THE REPORTER STATED THAT HE WAS UNAWARE OF AN ISSUES WITH THE PUMP AND WAS WILLING TO RETURN THE PUMP. ANIMAS HAS ATTEMPTED TO CONTACT THE PATIENT'S HEALTH CARE PROVIDERS BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS MADE BECAUSE WHILE THERE IS NO INDICATION OF ANY ISSUE WITH THE PRODUCT, THE PUMP COULD NOT BE RULED OUT AS A POSSIBLE 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 83 YR Death