BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 21598146 · Received March 13, 2025

    Report

    Report Number
    8021545-2025-00425
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 8, 2025
    Report Date
    June 25, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018723
    PMA / PMN Number
    K162812
    Adverse Event
    Yes
    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 FOR THE MALFUNCTION OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). NO ESCALATION REQUIRED. THE BATCH 6003486 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL (FLOW TEST) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003486 WAS MANUFACTURED ACCORDING TO THE WI VERSION 15 PACKAGED IN THE MULTIVAC 10, ON 29/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING THE LOT 3J03269 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 IN THE GLUING OF TUBING IN THE MACHINE SC08, ON 22/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES 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 19/JUN/2025 AGAINST MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6003486 NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. 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
    1701073 VARISOFT UNO COMFORT SHORT 80/13 TCAP 10PK INT FPA UNOMEDICAL A/S 1002828 6003486 05705244018723

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male