BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2616311 · Received June 14, 2012

    Report

    Report Number
    2531779-2012-05239
    Event Type
    Death
    Date Received
    June 14, 2012
    Date of Event
    March 13, 2012
    Report Date
    May 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THE FOLLOWING: THE LAST BOLUS WAS PERFORMED ON (B)(6) 2012 AT 10:08AM; THE PUMP'S FINAL BASAL DELIVERY OCCURRED ON (B)(6) 2012 AT 1:23PM; THE PUMP WAS SUSPENDED ON (B)(6) 2012 AT 1:26PM AND WAS NOT RESUMED. 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 AND NO ALARMS OCCURRING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012, ALLEGING THAT THE PATIENT PASSED AWAY ON (B)(6) 2012. THE PATIENT'S CAUSE OF DEATH ON THEIR DEATH CERTIFICATE IS LISTED AS METABOLIC ACIDOSIS AND DIABETES MELLITUS. THE REPORTER INDICATED THAT THE PATIENT HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS (READING HI ON THE METER) ON (B)(6) 2012. THE PATIENT WAS BEING CARED FOR AT A NURSING HOME AT THE TIME. THE PATIENT RECENTLY HAD SURGERY TO AMPUTATE A FOOT, AND WAS BEING TREATED WITH ANTIBIOTICS TO PREVENT INFECTION. THE PATIENT REPORTEDLY HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS FOR A FEW DAYS AFTER THE SURGERY; THE PATIENT'S NORMAL RANGE WAS BETWEEN 100 AND 120MG/DL, BUT WAS NOT ABLE TO MAINTAIN THIS POST SURGERY. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM ON (B)(6) 2012, DUE TO HIGH BLOOD GLUCOSE LEVELS; RESUSCITATION WAS ATTEMPTED AT THE HOSPITAL BUT THE PATIENT WAS PRONOUNCED DEAD ON (B)(6) 2012. THE REPORTER IS UNSURE OF THE EXACT TREATMENT PROVIDED IN THE ER, AND IF INJECTIONS WERE GIVEN TO TREAT THE HIGH BLOOD GLUCOSE LEVELS WHILE THE PATIENT WAS IN THE NURSING HOME. THE PUMP REPORTEDLY WAS BEING WORN BY THE PATIENT AT THE TIME OF DEATH. THE PUMP HISTORY WAS REVIEWED WITH THE REPORTER AND THE TIME AND DATE SETTINGS WERE FOUND TO BE CORRECT WHEN THE PUMP WAS BEING USED. THE BOLUS AND TOTAL DAILY DELIVERY HISTORY INDICATE THAT NO BOLUSES WERE DELIVERED VIA THE PUMP ON (B)(6). THE REPORTER WAS UNSURE IF BOLUSES WERE GIVEN VIA INJECTION AT THE NURSING HOME. THE TOTAL DAILY DELIVERY HISTORY WAS FOUND TO ADD UP CORRECTLY FOR BASAL AND BOLUS DELIVERIES. THE REPORTER INDICATED THAT THEY DO NOT BELIEVE THAT THE PUMP WAS THE CAUSE OF DEATH AND BELIEVES THAT THE PATIENT'S BLOOD GLUCOSE LEVELS WERE DIFFICULT TO CONTROL DUE TO THE SURGERY AND POSSIBLE INFECTION. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT PASSED AWAY RELATED TO METABOLIC ACIDOSIS AND DIABETES MELLITUS WHILE USING THE PUMP.

    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 41 YR Death| H