BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2425964 · Received January 13, 2012

    Report

    Report Number
    3004464228-2012-00012
    Event Type
    Death
    Date Received
    January 13, 2012
    Date of Event
    November 25, 2011
    Report Date
    December 15, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO DETERMINE IF THE CAUSE OF DEATH WAS DIABETES-RELATED OR IF THE DEVICE WAS ACTUALLY IN USE BY THE PATIENT AT THE TIME OF THE EVENT. NO PRODUCT WAS RECEIVED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OCCURRED. NO PRODUCT LOT INFORMATION WAS PROVIDED SO NO QUALIFICATION RECORDS REVIEW COULD BE PERFORMED. NO PRODUCT FAILURE MODE OR PATIENT CONDITION WAS SPECIFIED, THEREFORE NO LABELING REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 A CO-WORKER OF THE PATIENT CALLED TO REPORT THAT SHE HAD BEEN GOING THROUGH THE PATIENT'S VOICE MAIL AND HEARD NUMEROUS MESSAGES FROM INSULET. SHE STATED THAT THE PATIENT HAD BEEN FOUND BY HER DAUGHTER THE MORNING OF (B)(6) 2011 IN A SEMI-CONSCIOUS STATE WHICH HER DAUGHTER ASSUMED MEANT THE PATIENT WAS SUFFERING FROM HYPOGLYCEMIA. THE DAUGHTER TREATED HER MOTHER WITH STRAWBERRY MILK. THE PATIENT THEN BECAME UNCONSCIOUS, SO HER DAUGHTER CALLED PARAMEDICS AND PERFORMED CPR UNTIL THEY ARRIVED. THE PATIENT WAS ADMITTED THROUGH THE EMERGENCY ROOM WITH BLOOD GLUCOSE ABOVE 1200 MG/DL. ON (B)(6) 2011 INSULET CALLED THE PATIENT'S HCP OFFICE AND SPOKE WITH THE NURSE. SHE REPORTED THAT THEY HAD IN FACT TREATED THE PATIENT FOR SOME MAJOR HEALTH ISSUES ABOUT TWO WEEKS PRIOR BUT WERE NOT AWARE OF HER DEATH. SHE DID NOT ELABORATE ON WHAT SHE HAD BEEN TREATED FOR, BUT OFFERED TO SPEAK WITH THE DOCTOR AND CALL BACK IF THEY HAD ADDITIONAL INFORMATION. SHE DIDN'T CALL BACK. ON (B)(6) 2011 AN INSULET REPRESENTATIVE SPOKE WITH (B)(6) IN MEDICAL RECORDS AT (B)(6) HOSPITAL WHO SHE STATED A WRITTEN REQUEST WAS NEEDED IN ORDER TO OBTAIN THE LAST H AND P, CAUSE OF DEATH. (B)(6) ALSO STATED SHE WAS TRANSFERRED FROM THE (B)(6) HOSPITAL; THE PARAMEDICS TOOK HER TO THE (B)(6) HOSPITAL FIRST. A WRITTEN REQUEST FOR CAUSE OF DEATH, WHETHER THE DEVICE WAS BEING USED AND AVAILABILITY OF THE DEVICE FOR RETURN WAS SENT TO BOTH HOSPITALS. NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death