BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 20123386 · Received September 3, 2024

    Report

    Report Number
    3003442380-2024-23747
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    July 30, 2024
    Report Date
    February 27, 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

    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 6001420 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE (B)(4) ON 05/APR/2024. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WITH WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001420 WAS MANUFACTURED ACCORDING TO THE WI VERSION 75 MANUFACTURED IN THE LINE/MACHINE M12, ON 23/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, NO MAINTENANCE EVENTS WERE RECORDED. DHR REVIEW (GLUING TUBING): THE LOT 3E03662 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE LINE/MACHINE "GLUING 8", ON 23/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E03663 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE LINE/MACHINE "GLUING 5", ON 23/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E03664 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE LINE/MACHINE "GLUING 4", ON 22/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E03462 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE LINE/MACHINE MP05, ON 21/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E03658 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE LINE/MACHINE "GLUING 4", ON 18/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E03659 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE LINE/MACHINE "GLUING 8", ON 22/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E03661 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE LINE/MACHINE "GLUING 4", ON 20/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, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 20/FEB/2025 AGAINST MALFUNCTION TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6001420 AND 1 OTHER COMPLAINTS HAVE 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 REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, 1 OTHER COMPLAINT 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.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: (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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON 30-JUL-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET JOINT WAS DISCONNECTED AND HAD A BURR CUT, WHICH CAUSE THE PATIENT BLOOD GLUCOSE LEVELS WAS ELEVATED TO 400 MG/DL. THE PATIENT HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48HRS OF REPORTED HIGH BLOOD GLUCOSE LEVELS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734834 MINMED QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6001420 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown