BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21135928 · Received January 13, 2025

    Report

    Report Number
    3004464228-2025-01815
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 22, 2024
    Report Date
    April 7, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000432
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. [1] BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019; 13:614-626. [1] WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019; 10:751-755 [1] PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019; 21:155-158.

    Additional Manufacturer Narrative · 0

    INVESTIGATION FOUND NO DEFECTS OR DEFICIENCIES THAT WOULD CONTRIBUTE TO A FAILURE OF THE DEVICE¿S ABILITY TO DELIVER INSULIN OR RESULT IN BLEEDING OR BRUISING AT THE INFUSION SITE. NO BLOOD WAS OBSERVED ON THE RETURNED DEVICE. INSPECTION OF THE FORMED NEEDLE, SOFT CANNULA, AND BOTTOM HOUSING FOUND NO ABNORMALITIES. FLUID PATH TESTING SHOWED THAT FLUID WAS ABLE TO PASS OUT THE DISTAL TIP OF THE SOFT CANNULA. NO TIMEOUTS OR DRIVE STALLS WERE OBSERVED IN THE DATA THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN DURING OPERATION. THE PATIENT HISTORY BUFFER DATA FILES SHOWED THE ALGORITHM WAS FUNCTIONING AS INTENDED, CORRECTLY RESPONDING TO USER INPUTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS READ HIGH (>22.8 MMOL/L, >400 MG/DL) WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN THE POD WAS REMOVED FROM THE INFUSION SITE (LEG), THE SITE WAS NOTED TO BE BLEEDING AND THERE WAS A LUMP. AT THE HOSPITAL THE PATIENT WAS GIVEN A CT SCAN (AS THEY WERE EXPERIENCING LOSS OF SPEECH) AND TREATED WITH INSULIN. THE PATIENT WAS DISCHARGED AFTER 8 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478425 OMNIPOD 5 POD AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001443 PH1K03012451 20385083000432

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Hospitalization