BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 23449150 · Received November 3, 2025

    Report

    Report Number
    3003442380-2025-15692
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018457
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER, WAS SUBMITTED ON 04-NOV-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 03-MAY-2025. 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. COMPLAINT INVESTIGATION RESULTS: THE BATCH 6013136 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013136 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MULTIVAC 14, ON 03/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING: THE LOT 5D03590 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24 & LS25, ON 01/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D01338 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS07 & LS06 ON 01/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR: THE LOT 5D03569 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 01/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D03697 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 IN THE GLUING OF CONNECTOR IN THE LINE 07, ON 27/APR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D03570 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 02/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C04811 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 24/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D04822 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67 IN THE GLUING OF TUBE IN THE LINE SP08, ON 10/MAY/2025, 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. REVIEW OF THE DHR SHOWED THAT DURING THE OUTGOING TEST #8 AN EXTENDED WAS FOUND FOR NEEDLE GUARD MISSING IN ONE SAMPLE AND ONE MORE EXTENDED WAS FOUND FOR BENT NEEDLE IN ANOTHER SAMPLE AND THEREFORE THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS AT THE SITE. THE BLOOD GLUCOSE LEVEL WAS HIGH, AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. THE PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79206 CONTACT DETACH UNO CONTACT DETACH G29 80/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002834 6013136 05705244018457

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female