BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21016598 · Received December 25, 2024

    Report

    Report Number
    3003442380-2024-35181
    Event Type
    Malfunction
    Date Received
    December 25, 2024
    Date of Event
    December 1, 2024
    Report Date
    May 30, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01: MDR (B)(4). 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 6003966 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2081849 ON 27/MAY/2025 TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE DATABASE 2081849 COMPLAINT TEST REPORT. DHR REVIEW: THE LOT 6003966 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 45 MANUFACTURED IN THE LINE/MACHINE MULTIVAC 12, ON 28/OCT/2023 WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DHR REVIEW: THE LOT 3K03766 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE MACHINE SC1, ON 28/OCT/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3K03767 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE MACHINE SC1, ON 29/OCT/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3K03769 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE MACHINE SC1, ON 29/OCT/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 19/MAY/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE AND LOT 6003966 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003966 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, COMPLAINT CONFIRMED AS FAILURE OF THE DEVICE, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ARGENTINA. IT WAS REPORTED THAT, THE PATIENT FACED INFUSION SET CANNULA CRIMPED EVENT ON 01-DEC-2024. THE INSERTION SITE WAS LOWER BACK. INFUSION SET WAS IN USE FOR 10 HOURS. 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
    54997 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6003966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown