BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP® INSET

    MDR report key: 20513106 · Received October 23, 2024

    Report

    Report Number
    3003442380-2024-29558
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 23, 2024
    Report Date
    February 7, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MANUFACTURING DATE UNDER H4. 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. THIS LOT NUMBER 6006865 AND MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING) HAS BEEN EVALUATED THROUGH PREVIOUS COMPLAINT INVESTIGATION RECORDS: PR (B)(4) FOR THE SAMPLES EVALUATION, THEREFORE THE FORM- 001548 DOES NOT REQUIRE TO BE FILLED IN AGAIN AND THOSE TEST/REVIEW CAN BE LEVERAGED. TRENDING: A QUERY WAS RUN IN DATA ON 06-FEB-2025 AGAINST MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING) AND LOT 6006865 AND ANOTHER 1 COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: HARM NO REPORTABLE, NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY TWO COMPLAINTS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. 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. ON (B)(4) 2024, THE PATIENT REPORTED THAT THERE WAS OCCLUSION DURING THE FILLING PROCESS AND THE INSULIN LEAKED INTO THE PUMP. 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
    295418 YPSOPUMP® INSET UNO INSET II 46/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-046-52B6 6006865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown