BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21931915 · Received April 29, 2025

    Report

    Report Number
    3003442380-2025-07394
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 23, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    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 EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 FOR THE MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). THE BATCH 6010038 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES FOR BATCH 6010038 WERE PREVIOUSLY TESTED IN (B)(4) ON 21/JUN/2025. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (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. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING OF QUICK SET. THE LOT 6010038 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 AND PACKAGING IN THE MULTIVAC 12, ON 31/OCT/2024, WITH A TOTAL OF 28,500 UNITS. ASSEMBLY OF QUICK SET: THE LOT 4K05691 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 31/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05692 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 31/OCT/2024, 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 19/JUN/2025 AGAINST MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6010038 AND ANOTHER (B)(4) COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ANOTHER (B)(4) 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 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 SPAIN. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. 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
    1757472 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6010038 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown