BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23460610 · Received November 4, 2025

    Report

    Report Number
    3003442380-2025-15712
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 3, 2025
    Report Date
    October 22, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: UNITED STATES. 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 6013472, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 22-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6013472." THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013472 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 26-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5E04123 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 26-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5E04124 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 26-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5E05330 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 26-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E03432 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 04-08, ON 24-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E03433 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 04-08, ON 26-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E03435 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 04-08, ON 26-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. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TEST FOR COMPLAINTS AREA VERSION 3: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. WORK INSTRUCTION (WI) GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. 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 TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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 EXPERIENCED AN INSULIN FLOW BLOCKAGE ALARM EVENT ON (B)(6) 2025 DUE TO BLOOD ON TUBING AND GOT HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE (BG). THE BLOOD GLUCOSE (BG) AT THE TIME OF ADMISSION WAS 500 MG/DL WITH SYMPTOMS OF FEELING SICK/UNWELL, INCREASED THIRST, DIZZINESS/DEHYDRATION. THE PATIENT WAS TREATED WITH INTERAVENOUS FLUIDS AND INSULIN. THE LENGTH OF HOSPITALIZATION WAS LESS THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216594 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6013472 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention