BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24631926 · Received March 18, 2026

    Report

    Report Number
    3014585508-2026-14557
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    March 12, 2026
    Report Date
    March 26, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA/HYPOGLYCEMIA EVENT. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.6 OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 HARDWARE: N5004L CGM SENSOR TYPE: DATA NOT AVAILABLE PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 26 MARCH 2026, UPDATED LENGTH OF STAY IN HOSPITAL AND HOSPITAL DISCHARGE DATE IN B5 DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEVERE HYPOGLYCEMIC EPISODE FOLLOWING AN OMNIPOD TRAINING SESSION CONDUCTED ON (B)(6) 2026. ON THE MORNING OF THE TRAINING, THE PATIENT REPORTED ALREADY HAVING LOW BLOOD GLUCOSE LEVELS AND ADMINISTERED LANTUS INSULIN; THE PATIENT LATER STATED SHE WAS UNAWARE THAT CONTINUED LANTUS ADMINISTRATION WAS NOT PERMITTED AND BELIEVED THIS HAD NOT BEEN EXPLAINED. AFTER POD APPLICATION DURING TRAINING, THE PATIENT REPORTED A BLOOD GLUCOSE INCREASE TO 363 MG/DL AND SELF-ADMINISTERED 4 UNITS OF INSULIN VIA THE POD. AFTER, THE PATIENT LAY DOWN TO SLEEP AND SUBSEQUENTLY LOST CONSCIOUSNESS, WITH NO RECOLLECTION OF EVENTS THEREAFTER; SHE LATER REPORTED EXPERIENCING A SEVERE HYPOGLYCEMIC EPISODE ACCOMPANIED BY A BRIEF SEIZURE, NOTING A MEDICAL HISTORY OF EPILEPSY. THE PATIENT COULD NOT RECALL THE LOWEST BLOOD GLUCOSE VALUE AND BELIEVES THE POD MAY HAVE BEEN UNINTENTIONALLY REMOVED DURING THE EVENT. APPROXIMATELY 2.5 HOURS LATER, THE PATIENT WAS FOUND UNCONSCIOUS BY A FRIEND, GIVEN SUGAR WATER UPON REGAINING CONSCIOUSNESS, AND TRANSPORTED BY AMBULANCE TO LUTHERAN HOSPITAL BETHESDA. THE PATIENT WAS ADMITTED ON (B)(6) 2026 AT AND REMAINS HOSPITALIZED. THE PATIENT WAS TREATED WITH INSULIN. NO FURTHER INFORMATION WAS REPORTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEVERE HYPOGLYCEMIC EPISODE FOLLOWING AN OMNIPOD TRAINING SESSION CONDUCTED ON (B)(6) 2026. ON THE MORNING OF THE TRAINING, THE PATIENT REPORTED ALREADY HAVING LOW BLOOD GLUCOSE LEVELS AND ADMINISTERED LANTUS INSULIN; THE PATIENT LATER STATED SHE WAS UNAWARE THAT CONTINUED LANTUS ADMINISTRATION WAS NOT PERMITTED AND BELIEVED THIS HAD NOT BEEN EXPLAINED. AFTER POD APPLICATION DURING TRAINING, THE PATIENT REPORTED A BLOOD GLUCOSE INCREASE TO 363 MG/DL AND SELF-ADMINISTERED 4 UNITS OF INSULIN VIA THE POD. AFTER, THE PATIENT LAY DOWN TO SLEEP AND SUBSEQUENTLY LOST CONSCIOUSNESS, WITH NO RECOLLECTION OF EVENTS THEREAFTER; SHE LATER REPORTED EXPERIENCING A SEVERE HYPOGLYCEMIC EPISODE ACCOMPANIED BY A BRIEF SEIZURE, NOTING A MEDICAL HISTORY OF EPILEPSY. THE PATIENT COULD NOT RECALL THE LOWEST BLOOD GLUCOSE VALUE AND BELIEVES THE POD MAY HAVE BEEN UNINTENTIONALLY REMOVED DURING THE EVENT. APPROXIMATELY 2.5 HOURS LATER, THE PATIENT WAS FOUND UNCONSCIOUS BY A FRIEND, GIVEN SUGAR WATER UPON REGAINING CONSCIOUSNESS, AND TRANSPORTED BY AMBULANCE TO (B)(6). THE PATIENT WAS ADMITTED ON (B)(6) 2026 AT AND WAS DISCHARGED (B)(6) 2026, IN THE HOSPITAL 4 DAYS. ADDITIONALLY, THE PATIENT REPORTED SHE DOESN´T KNOW THE LOW BLOOD GLUCOSE LEVEL VALUES. THE PATIENT WAS TREATED WITH INSULIN. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370495 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1