BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 23631352 · Received November 24, 2025

    Report

    Report Number
    3003442380-2025-16947
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244005693
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4. 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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6013997, IN QUESTION WAS MANUFACTURED AT THE: REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 24-NOV-2025AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH" , "LOT NUMBER" CRITERIA EQUAL "6013997" . THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013997 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND MANUFACTURED IN THE MULTIVAC 14 ON 27-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT DURING THE FINAL INSPECTION OUTGOING, TEST NUM 8: A SAMPLE WAS FOUND WITH THE DAMAGED BLISTER. ACCORDING TO THE SAMPLING PLAN PERFORMED THE LOT WAS RELEASED. THE SUB-ASSEMBLY: WELDING LOT 5F04173 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE LS24, LS25 ON 25-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. WELDING LOT 5F04174 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE LS11, LS24, LS25, ON 27-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. WELDING LOT 5F04163 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34AND MANUFACTURED IN THE MACHINE LS06, LS07, ON 26-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF CONNECTOR: THE LOT 5F03888 WAS GLUED ACCORDING TO THE WI VERSION 40, LINE 3 AND MANUFACTURED, ON 25-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F03889 WAS GLUED ACCORDING TO THE WI VERSION 40, LINE 3 AND MANUFACTURED, ON 26-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F03941 WAS GLUED ACCORDING TO THE WI VERSION 40, LINE 3 AND MANUFACTURED, ON 27-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F03942 WAS GLUED ACCORDING TO THE WI VERSION 40, LINE 3 AND MANUFACTURED, ON 28-JUN-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. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED, THEREFORE, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) NOT CONFIRMED TO BE INFUSION SET RELATED (EX. TISSUE NO LONGER ABSORBING). ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TEST OF REFERENCE SAMPLES, A SAMPLING PLAN EXTENDED WAS PERFORMED DURING FINAL INSPECTION OUTGOING PROCESS NO RELATED TO COMPLAINT CODE, NO THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, 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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED THE INFUSION SET LEAKAGE ISSUE ON (B)(6) 2025. THE PATIENT REPORTED THAT UPON REMOVAL OF THE INFUSION SET, THE PATIENT OBSERVED MOISTURE AND LEAKAGE AROUND THE INFUSION SITE, INDICATING POTENTIAL INSULIN LOSS WHICH LEADS TO ELEVATED BLOOD GLUCOSE LEVELS PEAKING AT 380 MG/DL. THE PATIENT ALSO EXPERIENCED SYMPTOMS OF CONFUSION AND DISORIENTATION DURING THE HYPERGLYCEMIC EPISODE. THE PATIENT REPLACED THE INFUSION SET AND INSULIN DELIVERY WAS SUCCESSFULLY RESUMED. 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
    157916 CONTACT DETACH UNO CONTACT DETACH G29 60/6 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-863 6013997 05705244005693

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female