BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP INSET II

    MDR report key: 22209002 · Received June 16, 2025

    Report

    Report Number
    3003442380-2025-10626
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 19, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K032854
    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: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY - THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6010633 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE INCORRECT INSERTION OF THE SOFT CANNULA PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010633 WAS MANUFACTURED ACCORDING TO THE WI VERSION 75 AND PACKAGING IN THE LINE 5/MACHINE L158, ON 05/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 19/JUN/2025 AGAINST MALFUNCTION CODE INCORRECT INSERTION OF THE SOFT CANNULA AND LOT 6010633 AND ONE MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON THE VISUAL INSPECTION FOR REFERENCE SAMPLES, NO HARM REPORTED, ONE OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND REPORTED MALFUNCTION. 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 SPAIN. IT WAS REPORTED THAT THE PATIENT INCORRECTLY INSERTED THE CANNULA ON (B)(6) 2025 THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    1523140 YPSOPUMP INSET II UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 86-060-52B6 6010633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown