BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8540537 · Received April 23, 2019

    Report

    Report Number
    3004464228-2019-03436
    Event Type
    Death
    Date Received
    April 23, 2019
    Date of Event
    April 18, 2019
    Report Date
    April 19, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K162296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA, HOSPITALIZATION AND DEATH. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO LOT RELEASE RECORDS WERE REVIEWED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: ENT450, 17845-5C-AW REV A 10/17; CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36. WARNINGS: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNINGS: IF YOU GET RESULTS BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 117), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT HER HUSBAND'S BLOOD GLUCOSE (BG) WAS READING AT 30.5 MMOL/L (550 MG/DL), HE WAS DIZZY AND HAD SHORTNESS OF BREATH SO SHE CALLED HIS GENERAL PRACTITIONER (GP), WHO CAME TO THEIR HOME RIGHT AWAY. THE GENERAL PRACTITIONER INJECTED A MEDICATION (UNKNOWN) UNDERNEATH HIS TONGUE BECAUSE HE ALSO HAD HEART ISSUES. HE WAS THEN TAKEN TO THE HOSPITAL AND UPON ARRIVAL HIS BG ROSE TO 40.9 MMOL/L (737 MG/DL). HE STAYED IN THE HOSPITAL FOR 4 WEEKS DUE TO HIGH BG AND THAT HE HAD A LARGE WOUND ON HIS ANKLE CONTAINING A VIRUS WHICH SPREAD THROUGHOUT THE BLOOD, TAINTED HIS KIDNEYS, HIS BLADDER AND HIS LUNGES. HE ALSO HAS PARKINSON'S DISEASE. HER HUSBAND HAD PASSED AWAY WHILE AT THE HOSPITAL ON (B)(6) 2019 WITH BLOOD GLUCOSE READING BETWEEN 10 AND 13 MMOL/L (180 AND 234 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334420 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death