BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 19689141 · Received July 8, 2024

    Report

    Report Number
    3003442380-2024-13281
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 7, 2024
    Report Date
    October 16, 2025
    Manufacturer
    UNOMEDICAL A/S
    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 LOT NUMBER, 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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002116, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002116 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND MANUFACTURED IN THE MACHINE MULTIVAC 12 ON 12/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 3F05724 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP05 ON 08/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F05724 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP04 ON 09/JUL/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 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. NO PHYSICAL SAMPLES WERE RETURNED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, 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.

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GREECE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING DETACHMENT FROM THE CORRECT SITE TUBING CONNECTOR AT LEFT ABDOMEN. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPORTED THAT THERE WAS NOT STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272721 MINMED QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6002116 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown