BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8674223 · Received June 6, 2019

    Report

    Report Number
    3004464228-2019-04926
    Event Type
    Death
    Date Received
    June 6, 2019
    Date of Event
    May 22, 2019
    Report Date
    June 4, 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 DETERMINE IF ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPOGLYCEMIA AND DEATH. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: ENT450, 17845-5C-AW REV A 10/17; CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36. WARNING: TEST RESULTS BELOW 3.9 MMOL/L MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). 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. LIVING WITH DIABETES 9 / PAGE 121. HYPOGLYCEMIA CAN OCCUR EVEN WHEN A POD IS WORKING PROPERLY. NEVER IGNORE THE SIGNS OF LOW BLOOD GLUCOSE (NO MATTER HOW MILD). IF LEFT UNTREATED, SEVERE HYPOGLYCEMIA CAN CAUSE SEIZURES OR LEAD TO UNCONSCIOUSNESS. IF YOU SUSPECT THAT YOUR BLOOD GLUCOSE LEVEL IS LOW, CHECK YOUR BG LEVEL TO CONFIRM. LIVING WITH DIABETES 9 / PAGE 123. FREQUENT BLOOD GLUCOSE CHECKS ARE THE KEY TO AVOIDING POTENTIAL PROBLEMS. DETECTING LOW BLOOD GLUCOSE EARLY LETS YOU TREAT IT BEFORE IT BECOMES A PROBLEM.

    Description of Event or Problem · 1

    A DIABETES NURSE REPORTED THAT THE PATIENT PASSED AWAY IN A FATAL MOTORCYCLE ACCIDENT AROUND 18:00 ON (B)(6) 2019. THE FORENSIC DOCTOR HAD REQUESTED THE DIABETES NURSE TO INVESTIGATE THE OMNIPOD PRODUCT AS THE INVESTIGATION NOTICED THAT THE PATIENT HAD LOW BLOOD GLUCOSE (BG) READING OF 2.3 MMOL/L (41 MG/DL). IT WAS LIKELY THAT THE ACCIDENT WAS RELATED TO THE LOW BG LEVEL. THE DIABETES NURSE CHECKED EVERYTHING AND DID NOT SEE ANY ANOMALIES IN THE BASAL DELIVERY. THERE WAS NO BOLUS HISTORY AS HE TREATS HIS BG LEVEL WITH AN INSULIN PENS. THE DIABETES NURSE STATED THAT THE PATIENT WAS ALWAYS VERY SECURE AND PUNCTUAL WITH HIS DIABETES AND ALWAYS NOTICED TIMELY WHEN HIS BG LEVELS WERE LOW OR HIGH. THE DIABETES NURSE AND FORENSIC DOCTOR CONCLUDED THAT THIS DEATH WAS PROBABLY A TRAGIC ACCIDENT. THE LAST BG READING THAT WAS DONE BY THE PATIENT WAS 11.9 MMOL/L (214.2 MG/DL) AT 14:15. THE CAUSE OF THE DEATH WAS PHYSICAL INJURIES AS A CONSEQUENCE OF THE MOTORCYCLE ACCIDENT (NO SPECIFIC INJURIES PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468818 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44170 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death