BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD

    MDR report key: 4270189 · Received November 14, 2014

    Report

    Report Number
    MW5039147
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    September 25, 2012
    Report Date
    November 14, 2014
    Manufacturer
    INSULET CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 10/20/2015. FURTHER INFO IN REGARDS TO MY REPORT OF THE PT DEATH MDR (B)(4) ON (B)(6) 2014 AND A REPORT NUMBER MW5039147. THE PT DIED OF DKA. THE PUMP SHE WAS USING JUST PRIOR TO HER PASSING GAVE A HAZARD ALARM AT 4:36 AM AND ANOTHER AT 4:39 WHEN THE PUMP SHUT OFF STOPPING ANY INSULIN DELIVERY. THE PUMP FOUND ON HER BODY WAS WORKING PROPERLY BUT HAD BEEN CHANGED AFTER THE PREVIOUS FAILURE. THE EVENT WAS REPORTED TO (B)(6), GENERAL MANAGER OF YPSOMED LTD IN THE (B)(4). HE WAS ALSO THE REP WHO STARTED HER ON THE SYSTEM. HE STARTED HER AT HER RESIDENCE WITHOUT ANY ASSISTANCE FROM A QUALIFIED MEDICAL PERSON. THIS WAS AGAINST POLICY. THE HUSBAND OF THE DECEASED BELIEVED (B)(6) ULTIMATELY TOOK POSSESSION OF THE PUMP WHICH WAS NEVER BEEN RECOVERED. THE HOSPITAL DID HOWEVER DOWNLOAD PARTIAL DATA SHOWING THE PUMP FAILURE JUST PRIOR TO HER DEATH. I WAS MADE AWARE OF THE INCIDENT BY (B)(6) ALSO OF YPSOMED WHO STATED THAT ((B)(6)) NEVER REPORTED IT (BURIED IT) AS IT WAS HIS PT AND HE TRAINED HER. I EXPOSED IT SHORTLY AFTER FINDING OUT AND HAVE SINCE ACCEPTED A SETTLEMENT. I FORCED THE REPORT TO (B)(6), COMPLIANCE AT YPSOMED AG AND (B)(6), VP AT YPSOMED AG. I ALSO REPORTED IT DIRECTLY TO (B)(6) AT INSULET CORP., VIA EMAIL AROUND THE TIME OF MY REPORT TO THE FDA. I ALSO INFORMED THE NHRA. THIS EVENT WAS COVERED UP ON MANY LEVELS FOR WHICH I HOLD EVIDENCE AND ALSO BELIEVE THAT IT IS MORE PROBABLE THAN NOT THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. I WOULD GLADLY SPEAK TO AND/OR HAND OVER ANY EVIDENCE YOU MAY REQUEST ON THIS MATTER.

    Description of Event or Problem · 1

    (B)(6) THAT DIED ON (B)(6) 2012 OF DIABETIC KETOACIDOSIS. SHE WAS FOUND IN HER BEDROOM. SHE WAS USING AN INSULIN PUMP, OMNIPOD INSULIN PUMP, MANUFACTURED BY INSULET CORP. THE EVENT OCCURRED IN (B)(6) AND THE COMPANY, YPSOMED LTD., WAS NOTIFIED OF THE EVENT ON (B)(6) 2012 BY AT THE (B)(6) HOSPITAL IN (B)(6). SHE WAS INITIALLY STARTED IN THE US ON THE US SYSTEM BUT HAD BEEN SWITCHED OVER TO THE (B)(6) VERSION BY YPSOMED LTD. THE PATIENT DIED OF DIABETIC KETOACIDOSIS WHILE USING THE OMNIPOD PUMP BUT IS BELIEVED TO HAVE NOT BEEN REPORTED AS AN EVENT BUT RATHER ATTRIBUTED TO A PATIENT CONDITION WHEREIN THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. THIS IS NOW BEING QUESTIONED AS SHE HAD MULTIPLE FAILURES OF THE PUMP PRIOR TO HER DEATH AND IT IS BELIEVED THE PUMP WAS NEVER INVESTIGATED FOR PROPER FUNCTIONING BY A COMPETENT PERSON. WHILE DEAD-IN-BED SYNDROME IS COMMON IN TYPE 1 PATIENTS IT IS VIRTUALLY ALWAYS ASSOCIATED WITH HYPOGLYCEMIA AND NOT THE OPPOSITE DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735664 OMNIPOD OMNIPOD LZG INSULET CORP. UNK WHEREABOUTS OF DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death