BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH, PDM, PERSONAL DIABETES MANAGER

    MDR report key: 18271416 · Received December 5, 2023

    Report

    Report Number
    3004464228-2023-34299
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 8, 2023
    Report Date
    November 8, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K211575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE REPORTED ALLEGATION HAS BEEN REVIEWED AND EVALUATED. NO PHYSICAL PRODUCT INVESTIGATION IS REQUIRED IN THIS CASE BECAUSE EITHER THE PRODUCT IS NOT AVAILABLE FOR RETURN OR THE REPORTED EVENT DOES NOT MEET THE RISK-BASED CRITERIA REQUIRING PHYSICAL DEVICE INSPECTION. IF THIS IS A HIGHER RISK EVENT FOR WHICH WE WERE TOLD THE PRODUCT WAS UNAVAILABLE BUT WE LATER RECEIVE THE PRODUCT, AN INVESTIGATION OF THE RETURNED DEVICE WILL BE PERFORMED. ADDITIONALLY, INSULET CORPORATION HAS A DEFINED PROCESS FOR MONITORING, IDENTIFYING, AND ESCALATING UNFAVORABLE COMPLAINT TRENDS. COMPLAINT DATA IS A KEY PERFORMANCE INDICATOR (KPI) REVIEWED AS A PART OF, HOWEVER NOT LIMITED TO, COMPLAINT REVIEW AND MANAGEMENT REVIEW. THE OUTCOME OF THESE REVIEWS MAY WARRANT FURTHER ACTION, INVESTIGATION, OR ESCALATION AS PROCEDURALLY DEFINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) BATTERY WAS DRAINING VERY FAST AND WAS HOT TO TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123221 OMNIPOD DASH, PDM, PERSONAL DIABETES MANAGER PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000030 L000501

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female