BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 24798633 · Received April 7, 2026

    Report

    Report Number
    3014585508-2026-18585
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 7, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000432
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICAL DEVICE WAS NOT RETURNED FOR INVESTIGATION. REVIEW OF CLOUD DATA FROM THE INSULET CLOUD SYSTEM FOUND THAT A POD WITH THE SEQUENCE NUMBER REPORTED WAS USED BETWEEN 18:53 ON (B)(6) 2026 AND 13:56 ON (B)(6) 2026. THE CLOUD DATA FROM THIS PERIOD WAS DOWNLOADED AND REVIEWED. REVIEW OF THE PATIENT HISTORY BUFFER (PHB) DATA FOUND THAT THE POD WAS USED IN AUTOMATED MODE: LIMITED FOR THE FIRST 40 MINUTES OF USE DUE TO TEMPORARY SENSOR ERRORS, AS INDICATED BY ESTIMATED GLUCOSE VALUES OF -2. AFTER THE POD BEGAN RECEIVING VALID ESTIMATED GLUCOSE VALUES, INVALID ESTIMATED GLUCOSE VALUES WERE RECEIVED OCCASIONALLY, WITH NO STRETCHES THAT WOULD CAUSE THE SYSTEM TO TRANSITION TO AUTOMATED MODE: LIMITED OCCURRING AFTER THE INITIAL STRETCH. REVIEW OF THE PHB DATA FOUND THAT, WHILE IN AUTOMATED MODE, THE AUTOMATED ALGORITHM APPROPRIATELY ADJUSTED THE MICROBOLUS AMOUNTS BASED ON THE ESTIMATED GLUCOSE VALUES AND USER INPUTS. IN RESPONSE TO INCREASING AND HIGH ESTIMATED GLUCOSE VALUES, THE AUTOMATED ALGORITHM BEGAN DELIVERING THE MAX MICROBOLUS AMOUNT AS EXPECTED, EVENTUALLY RESULTING IN THE GENERATION OF AN AUTOMATED DELIVERY RESTRICTION ALERT AT 11:58 ON (B)(6) 2026. THE ALERT WAS ACKNOWLEDGED AND THE SYSTEM WAS TRANSITIONED TO MANUAL MODE AS EXPECTED. THE SYSTEM WAS USED IN MANUAL MODE UNTIL THE POD WAS DEACTIVATED, CORRECTLY DELIVERING THE USER'S MANUAL BASAL PROGRAM. NO EVIDENCE OF SIGNIFICANT POD-SENSOR COMMUNICATION LOSS OR ISSUES WITH INSULIN DELIVERY WERE OBSERVED IN THE AVAILABLE CLOUD DATA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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: 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

    AT THE TIME THE EVENT WAS REPORTED TO INSULET ON 09-MAR-2026, THE PATIENT REPORTED THEY HAVE BEEN IN HOSPITAL (B)(6) HOSPITAL) FOR A COUPLE DAYS DUE TO DIABETIC KETOACIDOSIS (DKA) (DKA WAS REPORTED UNDER INSULET REFERENCE NUMBER: (B)(4), FDA 3014585508-2026-14714, MHRA 2026/003/017/601/084). THE PATIENT REPORTED THEIR BLOOD GLUCOSE LEVEL ROSE TO 22 MMOL/L (396 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS ON THE ABDOMEN. THE PATIENT DECIDED TO REMOVE THE POD DUE TO THE ELEVATED BLOOD GLUCOSE LEVELS. AFTER THE POD WAS REMOVED, BLEEDING AND SLIGHT SWELLING WAS OBSERVED IN THE INFUSION SITE. INSULET RECEIVED ADDITIONAL INFORMATION ON 17-MAR-2026 FROM AN MHRA USER REPORT 2026/003/016/501/015. THE PATIENT REPORTED BOLUS INSULIN DOSES WERE RECORDED AS DELIVERED USING THE POD, BUT THEIR BLOOD GLUCOSE LEVEL DID NOT RESPOND AS EXPECTED, WITH PERSISTENT HYPERGLYCAEMIA. THE PATIENT REPORTED BEING SWITCHED INTERMITTENTLY BETWEEN AUTOMATED AND MANUAL MODES DUE TO MISSING SENSOR VALUES. THE PATIENT ATTEMPTED TROUBLESHOOTING INCLUDING REPLACING THE POD, CHANGING THE POD PLACEMENT SITE, USING PODS FROM A NEW BATCH, USING A NEW INSULIN VIAL, AND REPLACING THE CONTINUOUS GLUCOSE MONITORING SENSOR. HOWEVER, THE PATIENT REPORTED THEIR BLOOD GLUCOSE LEVEL ONLY IMPROVED AFTER INSULIN WAS ADMINISTERED VIA INTRAVENOUS INFUSION AND INSULIN INJECTION PENS. THE PATIENT WAS REPORTED TO HAVE STOPPED USING THE OMNIPOD SYSTEM AND RETURNED TO INSULIN INJECTIONS USING INSULIN PENS. ABBOTT WAS INFORMED OF THIS EVENT ON 19-MAR-2026. THIS IS POD 2 OF 2 (INSULET REFERENCE NUMBERS: (B)(4). THE POD WAS USED WITH THE PERSONAL DIABETES MANAGER REPORTED UNDER INSULET REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441579 OMNIPOD 5 POD AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001443 PH1K07142521 20385083000432

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention