BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 12439769 · Received September 8, 2021

    Report

    Report Number
    3004464228-2021-15748
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    July 28, 2021
    Report Date
    September 2, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED NOT DEPLOYED, WITH THE SLIDE INSERT NOT VISIBLE IN THE BOTTOM HOUSING. UPON OPENING THE DEVICE, THE NEEDLE MECHANISM DID NOT DEPLOY. DOWNLOAD DATA SHOWS THE POD COMPLETED 399 PULSES BEFORE BEING DEACTIVATED. THE DATA ALSO SHOWS AN 0X45, SMA WIRE 2 IS OPEN, ALARM WAS GENERATED DURING OPERATION. TIMEOUTS WERE ALSO SEEN IN THE DATA THAT CORRESPOND WITH THIS ALARM. THE DEVICE WAS SUCCESSFULLY PAIRED WITH PDM, COMPLETED PRIMING, AND ATTEMPTED TO DELIVER A 5U BOLUS. THE RERUN GENERATED A 0X42, ROTATIONAL SENSOR ALARM, AND CONTAINED ROTATIONAL SENSOR ERRORS. NO DAMAGES OR DEFECTS WERE OBSERVED TO THE SMA WIRE OR THE COMMUTATOR CAP THAT WOULD RESULT IN THE 0X45 ALARM OR THE ROTATIONAL SENSOR ERRORS. DURING THE RERUN, THE NEEDLE MECHANISM DEPLOYED NORMALLY. THE NEEDLE MECHANISM WAS RESET TO THE NON-DEPLOYED STATE AND THEN MANUALLY DEPLOYED BY ROTATING THE RATCHET GEAR. NO ISSUES WERE OBSERVED DURING THIS TEST THAT WOULD PREVENT THE NEEDLE MECHANISM FROM DEPLOYING AS INTENDED. INSPECTION OF THE TOP HOUSING FOUND SCORE MARKS THAT LINE UP WITH THE LINKAGE ASSEMBLY IN THE NON-DEPLOYED POSITION. INSPECTION OF THE LINKAGE ASSEMBLY UNDER MAGNIFICATION FOUND DAMAGE TO THE LINKAGE RIVET. THIS DAMAGE INDICATES FRICTION BETWEEN THE TOP HOUSING AND THE LINKAGE ASSEMBLY. THE INTERFERENCE OF THE TOP HOUSING WITH THE LINKAGE ASSEMBLY RESULTED IN THE NEEDLE MECHANISM NOT DEPLOYING AT THE END OF SECOND PRIME.D4 - SERIAL NO CHANGED FROM BLANK TO 0027496.D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (01)20385082000020(11)200926(17)220326(10)PD1C09262011(21)UNAVAILABLE TO (01)20385082000020(11)200926(17)220326(10)PD1C09262011(21)0027496.

    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. 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 CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. 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
    1336630 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C09262011 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male