BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2233453 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06454
    Event Type
    Death
    Date Received
    September 2, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAMILY MEMBERS HAVE REFUSED TO RETURN THE PUMP TO ANIMAS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2011; THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. A FAMILY MEMBER ALLEGED THAT THE PATIENT DIED AS THE RESULT OF BLOOD GLUCOSE (BG) EXCURSION BUT WAS UNWILLING TO SAY IF THE PATIENT'S BG WAS HIGH OR LOW AT THE TIME OF HER DEATH. IN ADDITION HE ALLEGED THAT THE TRAINING THEY RECEIVED ON (B)(6) 2011 IN THE USE OF THE PUMP WAS INADEQUATE. HE CLAIMED THAT THEY WERE NOT TOLD HOW TO MANAGE HIGH BG SITUATIONS. THE FAMILY MEMBER REPORTED THAT THE PATIENT'S BG WAS ELEVATED (>500MG/DL) DURING THE DAY AND EVENING BEFORE HER DEATH. HE SAID THAT HE WATCHED HER BOLUS THREE TIMES BETWEEN 1:50PM AND 9:30PM BUT HER BG REMAINED ELEVATED UNTIL 10:30PM. AT THAT TIME HER BG WAS ALLEGEDLY 107MG/DL AND HE RECALLED THAT HE RECOMMENDED THAT SHE CONSUME GLUCOSE TABS TO PREVENT HYPOGLYCEMIA OVERNIGHT. HE REPORTED THAT HE FOUND HER DEAD AT 8:15AM THE NEXT MORNING WITH THE BOTTLE OF GLUCOSE TABS IN HER HAND. THE FAMILY MEMBER STATED THAT HE REVIEWED THE BOLUS HISTORY AND THAT THERE WERE NO BOLUS RECORDS FOR MORE THAN 24 HOURS EVEN THOUGH HE ALLEGED THAT SHE HAD INDEED BOLUSED. HE STATED THAT THE BASAL DELIVERY HISTORY WAS ACCURATE. HE WAS NOT WILLING TO PROVIDE ANY FURTHER DETAILS ABOUT THE PUMP. THIS PATIENT EVENT IS BEING REPORTED BECAUSE OF THE ALLEGATION 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 58 YR Death