BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 24851276 · Received April 11, 2026

    Report

    Report Number
    3014585508-2026-19852
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    January 4, 2026
    Report Date
    April 11, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLOUD DATA FOR THE PERIOD OF (B)(6) 2026 WAS DOWNLOADED FOR REVIEW. INSPECTION OF THE PATIENT HISTORY BUFFER (PHB) AND POD MANAGER HISTORY (PMH) DATA INDICATES THAT THE POD WITH THE SERIAL NUMBER LISTED ON THE COMPLAINT PAGE (B)(6) WAS ACTIVATED ON (B)(6) 2026 AT 18:04:42. THE POD WAS FOUND TO GENERATE AN ALARM WITH ERROR CODE 19-01521-09651-205 AT (B)(6) 2026 AT 15:07:59 WHICH ALERTED THE USER THAT INSULIN DELIVERY STOPPED. CHANGE POD NOW.". THIS TRANSLATES TO AN 0XCD ALARM BEING GENERATED BY THE POD INDICATING "LOW VOLTAGE DETECTION BY ANALOG COMPARATOR 1. INSPECTION OF THE PHB DATA INDICATES THAT THE POD WAS IN AUTOMATED MODE FOR THE DURATION OF USE. THE SYSTEM WAS FOUND TO BE APPROPRIATELY ADJUSTING SUGGESTED INSULIN BASED ON ESTIMATED GLUCOSE VALUES (EGVS) RECEIVED BY THE POD AND USER INPUTS. ALL BOLUSES WERE FOUND TO BE FULLY DELIVERED AS INDICATED BY THE PULSE COUNT INCREASING WITH THE DELIVERED BOLUS VOLUME. THE USER'S EGVS WERE SHOWN TO START AT 293 MG/DL AND FOUND TO EVENTUALLY DECREASE TO NORMAL LEVELS HOWEVER WERE SHOWN TO INCREASE TO HIGH (GREATER THAN 401 MG/DL) BY THE TIME OF POD DEACTIVATION. NO PROBLEMS WERE FOUND WITH INSULIN DELIVERY BASED ON THE AVAILABLE CLOUD DATA FROM THE PMH AND PHB. HOWEVER, WITHOUT THE RETURNED POD, IT COULD NOT BE DETERMINED IF THERE WERE ANY DAMAGES OR DEFECTS WITH THE POD THAT WOULD CONTRIBUTE TO ISSUES WITH INSULIN DELIVERY OR THE REPORTED HAZARD ALARM. THE CAUSE OF THE REPORTED HAZARD ALARM COULD NOT BE DETERMINED. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. LOCKED DOWN SMARTPHONE: LOCKDOWN. OMNIPOD SOFTWARE APP VERSION: 3.1.1. OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06. HARDWARE: N5004L. CGM SENSOR TYPE: G7. 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

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO GREATER THAN 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THEIR BACK. THE PATIENT STATED THEY RECEIVED AN ERROR MESSAGE DURING A BOLUS THAT STOPPED THE INSULIN DELIVERY. AS TREATMENT, A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210699 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U08182531 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male