BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 21016492 · Received December 25, 2024

    Report

    Report Number
    3003442380-2024-35037
    Event Type
    Malfunction
    Date Received
    December 25, 2024
    Date of Event
    November 30, 2024
    Report Date
    May 31, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    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 STATES.

    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 REFERENCE SAMPLES FOR THE LOT 6002747 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL AND FLOW IN THE COMPLAINT (B)(4) ON (B)(4) 2025. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT 2002424 TEST REPORT. PDF ATTACHED IN THIS RECORD. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: PACKAGING LOT: THE 6002747 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 110 ON THE PACKING PROCESS IN THE MACHINE MULTIVAC 12 ON 22/AUG/2023, WITH A TOTAL OF 57,000 UNITS. ASSEMBLY LOT: THE LOT 3H00740 WAS ASSEMBLED ACCORDING TO WORK INSTRUCTION (WI) VERSION 26 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 21/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00741 WAS ASSEMBLED ACCORDING TO WI VERSION 26 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 22/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00742 WAS ASSEMBLED ACCORDING TO WI VERSION 26 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 22/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 3H02408 WAS ASSEMBLED ACCORDING TO WI VERSION 39 MANUFACTURED IN THE MACHINE MP05, ON 19/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H02409 WAS ASSEMBLED ACCORDING TO WI VERSION 39 MANUFACTURED IN THE MACHINE MP05, ON 20/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H02422 WAS ASSEMBLED ACCORDING TO WI VERSION 39 MANUFACTURED IN THE MACHINE MP08, ON 19/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H02423 WAS ASSEMBLED ACCORDING TO WI VERSION 39 MANUFACTURED IN THE MACHINE MP04, ON 21/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 30/MAY/2025 AGAINST MALFUNCTION CODE TUBING IS DAMAGED (E.G., KINKED, DEFORMED, TWISTED, COLLAPSED, OR PINCHED) AND LOT 6002747 AND ONE MORE COMPLAINT HAVE BEEN REGISTERED IN DATABAS FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINTS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. 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 INFUSION SET TUBING BENT EVENT ON (B)(6) 2024. NO FURTHER INFORMATION WAS 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
    80324 MINMED QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6002747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown