BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 22083612 · Received May 26, 2025

    Report

    Report Number
    3003442380-2025-09651
    Event Type
    Malfunction
    Date Received
    May 26, 2025
    Date of Event
    May 5, 2025
    Report Date
    June 12, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017931
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES.

    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. THE BATCH 6001587 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3.0 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2.0 FOR THE CODE ADD MALFUNCTION CODE. COMPLAINT INVESTIGATIONS: PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL LEAK TEST 2 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING OF QUICK SET. THE LOT 6001587 WAS MANUFACTURED ACCORDING TO THE WI VERSION 75 AND PACKAGING IN THE MULTIVAC 08, ON 30/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICK SET: THE LOT 3E04524 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 29/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF QUICK SET THE LOT 3E04500 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP08, ON 29/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E01482 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP04, ON 08/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E04495 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP04, ON 29/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E04450 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP04, ON 29/MAY/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 05/JUN/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS AND LOT 6005187 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6005187 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, HARM NO REPORTABLE, 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 NON-CONFORMANCE (NC) 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 ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED EVENT OF LEAKAGE AT QUICK RELEASE ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 400 MG/DL WHICH WAS TREATED BY MANUAL INJECTION. THE SITE WAS THIGH AND INFUSION SET WAS USED FOR TWO DAYS. 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
    1014058 MINMED QUICK SET UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-398A 6001587 05705244017931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown