BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 16755823 · Received April 17, 2023

    Report

    Report Number
    3004464228-2023-09780
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 6, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000051
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D1 - BRAND NAME: OMNIPOD 5 POD HAS BEEN UPDATED TO OMNIPOD DASH INSULIN MANAGEMENT SYSTEM. D2A - COMMON DEVICE NAME: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP HAS BEEN UPDATED TO PUMP, INFUSION, INSULIN. D2B - PROCODE: QFG HAS BEEN UPDATED TO LZG. D4 - MODEL # : PT-000435 HAS BEEN UPDATED TO 18325. D4 - CATALOG #: POD-BLE-H1-520 HAS BEEN UPDATED TO BLE-P1-525. D4 - SERIAL #: HAS BEEN UPDATED TO (B)(6). D4 - UNIQUE IDENTIFIER (UDI) #: (B)(4) HAS BEEN UPDATED TO (B)(4). G4 - PMA/510(K) #: K203768 HAS BEEN UPDATED TO K211575.

    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 CUSTOMER'S INFUSION SITE INFECTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE WHILE WEARING THE DEVICE BETWEEN 4 AND 24HOURS. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2023. THE PATIENT RECEIVED 2 ANTIBIOTICS WHILE AT THE EMERGENCY ROOM AND WAS RELEASED THE SAME DAY. THE PATIENT THEN WENT TO SEE THEIR ENDOCRINOLOGIST ON (B)(6)2023 AND THEY HAD THEIR INFECTION LANCED, DEBRIDED, AND CULTURED. ON FOLLOW UP WITH THE ENDOCRINOLOGIST THE PATIENT REPORTED THAT THEIR INFECTION HAD BEEN DIAGNOSED AS A STAPH INFECTION. THE PATIENT WAS PRESCRIBED A DIFFERENT ANTIBIOTIC AFTER THIS. THE PATIENT DID NOT RECALL WHICH ANTIBIOTICS THEY RECEIVED. THE POD WAS REMOVED BEFORE SEEKING MEDICAL TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE WHILE WEARING THE DEVICE BETWEEN 4 AND 24HOURS. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2023. THE PATIENT RECEIVED 2 ANTIBIOTICS WHILE AT THE EMERGENCY ROOM AND WAS RELEASED THE SAME DAY. THE PATIENT THEN WENT TO SEE THEIR ENDOCRINOLOGIST ON (B)(6)2023 AND THEY HAD THEIR INFECTION LANCED, DEBRIDED, AND CULTURED. ON FOLLOW UP WITH THE ENDOCRINOLOGIST THE PATIENT REPORTED THAT THEIR INFECTION HAD BEEN DIAGNOSED AS A STAPH INFECTION. THE PATIENT WAS PRESCRIBED A DIFFERENT ANTIBIOTIC AFTER THIS. THE PATIENT DID NOT RECALL WHICH ANTIBIOTICS THEY RECEIVED. THE POD WAS REMOVED BEFORE SEEKING MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807390 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18325 20385082000051
    507391 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18325 20385082000051

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Hospitalization