BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10440504 · Received August 22, 2020

    Report

    Report Number
    3004464228-2020-13483
    Event Type
    Malfunction
    Date Received
    August 22, 2020
    Date of Event
    August 19, 2020
    Report Date
    August 19, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K162296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED NOT DEPLOYED. A DRIVE STALL OCCURRED DURING THE POD'S RUN, CAUSING THE RATCHET GEAR NOT TO BE SUFFICIENTLY ROTATED TO RELEASE THE RELEASE BAR AND DEPLOY THE NEEDLE MECHANISM. THIS GENERATED AN 0X40 ALARM IN THE DOWNLOAD DATA. THE DRIVE STALL WAS REPLICATED DURING TESTING WHEN THE HOOK TALON WAS OBSERVED FAILING TO DETENT THE RATCHET GEAR. DAMAGED RATCHET GEAR TEETH WERE FOUND DURING INVESTIGATION, CAUSING THE FAILURE TO DETENT AND THE FAILURE TO DEPLOY THE NEEDLE AS INTENDED.****PER NEW INFORMATION, THE FOLLOWING WERE UPDATED*** D1 - BRAND NAME CHANGED FROM OMNIPOD INSULIN PUMP TO OMNIPOD INSULIN MANAGEMENT SYSTEM. D4: MODEL NO CHANGED FROM 14810 TO 19191. D4: LOT NO CHANGED FROM BLANK TO L45416. D4: CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4: EXPIRATION DATE CHANGED FROM BLANK TO 7/12/2021. D4: UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). G5: PMA/510(K) # CHANGED FROM K192659 TO K162296. H4: DEVICE MFG DATE CHANGED FROM BLANK TO 1/12/2020.

    Additional Manufacturer Narrative · 1

    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 CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE DID NOT DEPLOY, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS WORN FOR LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904828 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45416

    Patients

    Seq Age Sex Outcome Treatment
    1