BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2233215 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06452
    Event Type
    Death
    Date Received
    September 2, 2011
    Date of Event
    August 2, 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
    NC, 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. 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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2011; THE REPORTED CAUSE OF DEATH WAS CARDIAC ARREST SECONDARY TO DIABETIC KETOACIDOSIS. THE FOLLOWING SEQUENCE OF EVENTS WAS REPORTED AND VERIFIED BY AT LEAST TWO OF THE PATIENT'S HEALTH CARE PROVIDERS. THE FAMILY MEMBER WHO WITNESSED THE PATIENT'S DEATH HAS BEEN UNABLE OR UNWILLING TO PROVIDE INFORMATION. IT WAS SAID THAT THE PATIENT HAD ELEVATED BLOOD GLUCOSES (BG) BETWEEN 200MG/DL AND 300MG/DL AND THAT THE PATIENT HAD EXPERIENCED A COUGH AND CONGESTION FOR SEVERAL DAYS PRIOR TO HIS DEATH. IT WAS REPORTED THAT THE FAMILY MEMBER VISITED THE PATIENT'S PHYSICIAN'S OFFICE ON (B)(6) 2011 TO OBTAIN INSULIN AND SYRINGES. IT WAS REPORTED THAT THE PUMP LOST PRIME ON SEVERAL OCCASIONS ON THE NIGHT BEFORE THE PATIENT DIED. DURING THE NIGHT, SHE HEARD THE ALARM, ENTERED HIS ROOM, AND REMOVED THE PUMP. IT WAS SAID THAT SHE TOOK THE PUMP INTO ANOTHER ROOM TO CLEAR THE ALARM AND FOUND HIM UNCONSCIOUS WHEN SHE RETURNED TO RECONNECT HIM TO THE PUMP. SHE CALLED 911; HE WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL WHERE HE WAS PRONOUNCED DEAD. ACCORDING TO THE PATIENT'S PHYSICIANS, HE WAS DIAGNOSED WITH TYPE 1 DIABETES IN 2004 AND BEGAN INSULIN PUMP THERAPY IN 2007. HIS HEMOGLOBIN A1C HAD RECENTLY RISEN TO 9.0% ON (B)(6) 2011 WITH PRIOR VALUE OF 8.2%. AT THAT TIME HIS PHYSICIAN MADE PUMP SETTING ADJUSTMENTS AND NOTED THAT HE WAS NOT BOLUSING MIDDAY. THE PHYSICIAN REPORTED THAT THE FAMILY WAS NOT USING THE PUMP TO CALCULATE BOLUS DOSAGES AND WERE DETERMINING DOSAGES MANUALLY. THE FAMILY MEMBER NOTED DURING THE VISIT THAT THE PATIENT'S BLOOD GLUCOSE METER HAD GIVEN INACCURATE BG READINGS. THIS COMPLAINT HAS BEEN FORWARDED TO THE MANUFACTURER OF THE METER. THIS PATIENT EVENT IS BEING REPORTED BECAUSE IT IS UNKNOWN IF 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 11 YR Death