BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP INSET

    MDR report key: 19295798 · Received May 12, 2024

    Report

    Report Number
    3003442380-2024-00979
    Event Type
    Malfunction
    Date Received
    May 12, 2024
    Report Date
    October 8, 2024
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H11: INVESTIGATION SUMMARY. THE INFORMATION OF THIS COMPLAINT HAS BEEN EVALUATED. SINCE NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH POST MARKETING SURVEILLANCE PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD HAVE FLAGGED ON THE TRIPS AND ALERTS ACCORDING TO THE MARKET QUALITY REVIEW (MQR) PROCEDURE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT FACED OCCLUSIONS DURING BOLUS DELIVERY. THE PATIENT RECEIVED FIASP INSULIN. THIS REMAINS IN YPSOPUMP FOR APPROXIMATELY TWO DAYS. THE INFUSION SET WAS CHANGED FOR EVERY 2-3 DAYS. INSULIN WAS WARMED TO ROOM TEMPERATURE FOR APPROXIMATELY 30 MINUTES. THE INSULIN WAS PLACED IN THE ABDOMEN AND CHANGED REGULARLY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970686 YPSOPUMP INSET UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown