BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2181871 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05380
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS 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. THERE ARE NO COMPLAINTS AGAINST THIS PUMP ON RECORD DURING THE TIME THE PATIENT USED IT. BASAL AND BOLUS INSULIN DELIVERY HISTORY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WAS NO EVIDENCE OF AN ALARM OR MALFUNCTION DURING THE TIME LEADING UP TO THE PATIENT'S DEMISE. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OR ALARMS. (B)(6).

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT WAS FOUND DEAD AT HOME ON (B)(6) 2011. SHE STATED THAT THE PHYSICIAN TOLD HER THE CAUSE OF DEATH ON THE DEATH CERTIFICATE WOULD READ NATURAL CAUSES. THE FAMILY MEMBER STATED THAT SHE BELIEVED THAT HIGH BLOOD GLUCOSE CONTRIBUTED TO THE PATIENT'S DEATH BUT SHE DENIED ANY IMPLICATION THAT THE PUMP MAY HAVE CAUSED OR CONTRIBUTED TO HIS DEMISE. SHE NOTED THAT THE PATIENT HAD MANY HEALTH ISSUES IN ADDITION TO DIABETES THAT INCLUDED BUT WERE NOT LIMITED TO (B)(6), CONGESTIVE HEART FAILURE, KIDNEY FAILURE, AND NEUROPATHY. THE FAMILY MEMBER REPORTED HER ACCOUNT OF THE HOURS LEADING UP TO HIS DEATH; THE PUMP AND METER REMOTE WERE RETURNED TO ANIMAS FOR EVALUATION. TOGETHER THE FOLLOWING SEQUENCE OF EVENTS HAS BEEN ESTABLISHED. ACCORDING TO THE METER REMOTE HISTORY, ON (B)(6) 2011 THE PATIENT'S FIRST BG WAS 55MG/DL AT 8:59AM. AT 11:37AM THE RECORDED BG WAS 147MG/DL AND A MEALTIME BOLUS WAS PROGRAMMED AND DELIVERED. AT 2:30PM THE BG WAS 464MG/DL AND A CORRECTION BOLUS WAS DELIVERED. THE PATIENT APPARENTLY TESTED AGAIN AT 6:00PM ON (B)(6) 2011 AND HIS BG WAS 650MG/DL AT WHICH TIME THE FAMILY MEMBER TOOK HIM TO THE EMERGENCY ROOM WHERE HE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. SHE NOTED THAT SHE WAS NOT WITH HIM IN THE EMERGENCY ROOM BUT BELIEVES THAT THE PUMP WAS REMOVED AND THAT THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AND INSULIN. THE PUMP HISTORY INDICATES DELIVERY WAS SUSPENDED BETWEEN 9:00PM AND 1:30AM. THE FAMILY MEMBER SAID THAT THE PATIENT WAS TREATED IN THE EMERGENCY ROOM UNTIL ABOUT 1:00AM. AROUND THAT TIME A BG READING ON THE METER REMOTE AT 1:01AM REPORTED 503MG/DL AND AT 1:38AM THE READING WAS 530MG/DL. THE PUMP WAS PRIMED AND A CORRECTION BOLUS WAS DELIVERED AROUND 1:39AM. THE NEXT AND LAST BG READING ON THE METER REMOTE WAS AT 8:56AM (883MG/DL) WITH NO ASSOCIATED DELIVERY ATTEMPT. THE FAMILY MEMBER CALLED HIM AROUND THE SAME TIME; THE PATIENT TOLD HER HIS BG WAS HIGH BUT NOT AS HIGH AS (B)(6) AND THAT HE WAS TIRED. HE WAS FOUND DEAD AT AROUND 6:00PM (B)(6). THE FAMILY MEMBER STATED THAT THE PUMP WAS FOUND ON THE FLOOR NEAR THE PATIENT WITH THE TUBING AND INSERTION SET ATTACHED; SHE SAID IT LOOKED AS IF THE SET HAD BEEN PULLED OUT BUT SHE WAS UNABLE TO DESCRIBE THE DEVICES IN ANY OTHER DETAIL. THIS COMPLAINT IS BEING REPORTED BECAUSE USE ERROR CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE PATIENT'S DEATH.

    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 53 YR Death