BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23520518 · Received November 11, 2025

    Report

    Report Number
    3003442380-2025-16015
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 4, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K991759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-16015), WAS SUBMITTED ON 11-NOV-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 16-MAR-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. A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011972, IN QUESTION WAS MANUFACTURED AT THE: REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 04-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6011972". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011972 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MACHINE 12 ON 16-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, LOT 5C01449 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 ON 15-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, LOT 5C01450 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 ON 16-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING OF THE LOT # 5C00162 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 4 AND 8, ON 13-MAR-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: NO PHOTO WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE 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 FLOW TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, ONE COMPLAINT 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 OCCURED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 495 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) INSULIN. 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
    1877508 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6011972 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention