BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YPSOPUMP INSET

    MDR report key: 21771531 · Received April 4, 2025

    Report

    Report Number
    3003442380-2025-05574
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 15, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. THE REFERENCE SAMPLES FOR THE LOT 6010266 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 23/MAR/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE (B)(4) COMPLAINT TEST REPORT.PDF ATTACHED IN THIS RECORD. DEVICE HISTORY RECORD (DHR) REVIEW THE LOT 6010266 WAS MANUFACTURED ACCORDING TO THE WI VERSION 75 MANUFACTURED IN THE LINE 6, ON 24/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 14/APR/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6010266 AND OTHER NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6010266 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF ON (B)(6) 2024 WHERE PATIENT INSERTED INFUSION SET IN THE AFTERNOON AND HAD RAPIDLY INCREASING AND STAGNATING HIGH GLUCOSE LEVELS. ON (B)(6) 2025, THE GLUCOSE CONTINUED TO RISE WHICH RESULTED IN ADMISSION TO THE HOSPITAL AND PATIENT WAS GIVEN ADDITIONAL INSULIN VIA PEN. THE SYMPTOMS OF KETOACIDOSIS WERE ALREADY VERY PRONOUNCED AT THIS POINT. IN THE AFTERNOON PATIENT NOTICED THAT THE CANNULA PLASTER WAS WET. PATIENT CONFIFMED THE CANNULA WAS BENT. 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
    2371841 YPSOPUMP INSET UNO INSET II 60/9 GREY Y-CAP 10PAK INT FPA UNOMEDICAL UM-D 86-060-52B9 6010266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R