BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 24884615 · Received April 15, 2026

    Report

    Report Number
    3014585508-2026-20583
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    December 26, 2025
    Report Date
    April 15, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000432
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION, EMERGENCY CAESARIAN DELIVERY AND DIABETIC KETOACIDOSIS. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.5-P001 OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 HARDWARE: N5004L CGM SENSOR TYPE: L2+. 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.

    Description of Event or Problem · 0

    THIS REPORT CONCERNS THE BABY. ON (B)(6) 2025, WHILE THE MOTHER WAS APPROXIMATELY 29 WEEKS PREGNANT AND WEARING AN INSULIN DELIVERY POD THAT HAD BEEN IN USE FOR APPROXIMATELY 25 TO 36 HOURS, MATERNAL BLOOD GLUCOSE LEVELS ROSE RAPIDLY TO A REPORTED MAXIMUM OF 22 MMOL/L (396 MG/DL). DURING THIS TIME, THE MOTHER EXPERIENCED ABDOMINAL PRESSURE AND PERCEIVED A CHANGE IN FETAL POSITION, DESCRIBED AS THE BABY DROPPING LOWER IN THE ABDOMEN. MULTIPLE INSULIN BOLUSES WERE ADMINISTERED; HOWEVER, HYPERGLYCEMIA PERSISTED. THE MOTHER SOUGHT URGENT MEDICAL CARE, AND BOTH THE MOTHER AND THE BABY WERE DIAGNOSED WITH DIABETIC KETOACIDOSIS, INDICATING IN-UTERO COMPROMISE OF THE BABY. AN EMERGENCY CAESAREAN SECTION WAS PERFORMED THE SAME DAY. INSULIN THERAPY WAS ADMINISTERED TO THE MOTHER DURING HOSPITALIZATION, INCLUDING NOVORAPID INJECTIONS AND INSULIN DURING SURGERY; SPECIFIC INTRAOPERATIVE DETAILS WERE NOT DOCUMENTED. THE BABY WAS DELIVERED PREMATURELY AT 29 WEEKS¿ GESTATION AND REQUIRED PROLONGED HOSPITALIZATION. THE BABY REMAINED HOSPITALIZED FOR APPROXIMATELY TWO MONTHS AND WAS DISCHARGED HOME WITH THE MOTHER ON (B)(6) 2026. NO BLOOD GLUCOSE MEASUREMENTS FOR THE BABY WERE REPORTED. THE POD IN USE DURING THE EVENT WAS REMOVED BY HOSPITAL STAFF AND DISCARDED; THEREFORE, IT WAS NOT AVAILABLE FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389455 OMNIPOD 5 POD AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001443 PH1M02262511 20385083000432

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Hospitalization| R