BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP INSET

    MDR report key: 19284112 · Received May 10, 2024

    Report

    Report Number
    3003442380-2024-00254
    Event Type
    Malfunction
    Date Received
    May 10, 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 SURVELLIENCE 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 CANNULAS OF THE INSETS BENT WHEN THEY WERE INSERTED. ALSO, MENTIONED IT WAS PROBABLY A HANDLING PROBLEM. THE CUSTOMER NOTICED A SLIGHT BURNING SENSATION WHEN INSULIN WAS ADMINISTERED. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. 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
    1039479 YPSOPUMP INSET UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown