BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 13694201 · Received March 8, 2022

    Report

    Report Number
    3004464228-2022-03983
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 1, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    Product Problem
    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. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO 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.

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED. THE SOFT CANNULA MEASURED THE CORRECT FULL LENGTH ACCORDING TO SPECIFICATION AND DID NOT APPEAR DAMAGED. INSPECTION OF THE FLUID PATH AND NEEDLE MECHANISM COMPONENTS FOUND NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD RESULT IN THE SOFT CANNULA BECOMING DISLODGED FROM THE INFUSION SITE. A ROOT CAUSE FOR THE REPORTED DISLODGED CANNULA COULD NOT BE DETERMINED. THE DEVICE WAS RECEIVED WITH THE ADHESIVE PAD ATTACHED TO THE BOTTOM HOUSING, AND NO DAMAGES OR DEFECTS WERE OBSERVED WITH THE ADHESIVE PAD OR THE ADHESIVE PAD'S WELDS. THE CAUSE OF THE REPORTED ADHESIVE FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO: D1 - BRAND NAME CHANGED FROM " " TO "OMNIPOD 5 POD". D2A - COMMON DEVICE NAME CHANGED FROM " " TO "ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP". D2B - PROCODE CHANGED FROM " " TO "QFG". D4 - CATALOG NO CHANGED FROM " " TO "POD-BLE-H1-520". D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM " " TO (B)(4). PP1K10142111(21)0040002". G4 - PMA/510(K) # CHANGED FROM " " TO "K203768". H5 - LABELED FOR SINGLE USE CHANGED FROM "NONE SELECTED" TO "YES".

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 598 MG/DL WHILE WEARING THE POD ALL NIGHT AND ALL DAY. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, SKIN TAC AND AN OVERLAY WERE APPLIED TO ATTEMPT TO RE-ADHERE THE POD. THE POD WAS PLANNED TO BE REMOVED AND A NEW ONE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139213 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K10142111 10385083000114
    2942251 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K10142111 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male