BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 10369136 · Received August 5, 2020

    Report

    Report Number
    3004464228-2020-12460
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 4, 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 POD WAS RECEIVED WITH THE CANNULA DEPLOYED. THE DOWNLOAD DATA SHOWED THAT THE DEVICE RAN 55 PULSES AND WAS DEACTIVATED AFTER COMPLETION OF THE SECOND PRIMING SEQUENCE. NO ISSUES WERE FOUND THAT WOULD RESULT IN A NEEDLE MECHANISM FAILURE. IT COULD NOT BE DETERMINED WHEN THE NEEDLE DEPLOYED. A ROOT CAUSE FOR THE REPORTED NEEDLE DEPLOYING LATE COULD NOT BE DETERMINED. A CRACK WAS FOUND ON THE OUTER HOUSING. IT COULD NOT BE DETERMINED WHEN THIS CRACK HAD OCCURRED.

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION THE FOLLOWING WERE UPDATED: D4 - MODEL NO CHANGED FROM 14810 TO 19191. D4 - LOT NO CHANGED FROM BLANK TO L45702. D4 - CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4 - EXPIRATION DATE CHANGED FROM BLANK TO 10/12/2021. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO (B)(4). G5 - PMA/510(K) # CHANGED FROM K192659 TO K162296. H4 - DEVICE MFG DATE CHANGED FROM BLANK TO 4/12/2020.

    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 DEPLOYED LATE, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831578 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45702

    Patients

    Seq Age Sex Outcome Treatment
    1