BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21208073 · Received January 22, 2025

    Report

    Report Number
    3003442380-2024-37741
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 30, 2024
    Report Date
    November 27, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    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

    MDR (B)(4). MDR 3003442380-2024-37741. 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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001424, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 26/NOV/2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH" , "LOT NUMBER" CRITERIA EQUAL "6001424". THE COUNT OF COMPLAINT IS 8 WHICH IS EXCEEDS 3. FURTHER INVESTIGATION IS REQUIRED VIA CAPA DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001424 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 AND PACKAGING IN THE MACHINE MULTIVAC 12 ON 26/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. A NON-CONFORMANCE (NC) WAS RAISED DUE TO STERILIZATION PROCESS. THIS NC IS NOT RELATED TO CLAIMED MALFUNCTION. TEST RESULTS: NO PHOTO WAS PROVIDED. TO PROCEED WITH PRODUCT TESTING, SAMPLES FROM THE AFFECTED LOT WERE REQUESTED. HOWEVER, THE CUSTOMER HAS CONFIRMED THAT NO SAMPLES ARE AVAILABLE FOR INVESTIGATION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES OR PHOTOGRAPHIC EVIDENCE HAVE BEEN SUBMITTED FOR ANALYSIS, ONE NONCONFORMANCE (NC) WAS RAISED DURING THE STERILIZATION PROCESS, AND FOUND UNRELATED TO THE REPORTED MALFUNCTION CODE, THE THRESHOLDS OF 3 REPORTABLE COMPLAINTS IS MET FOR THE LOT IN QUESTION AND MALFUNCTION CODE, FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). DEVICE 6 OF 7. E1: (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 THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT PATIENT FACED SEVEN INFUSION SET PACKAGING ISSUE EVENTS ON 30-DEC-2024. THE PACKAGES WERE NOT SEALED PROPERLY MISSHAPED VACUUMED AND LOOKED STEAMY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541298 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6001424 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown