BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 21397130 · Received February 18, 2025

    Report

    Report Number
    3003442380-2025-01540
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 18, 2025
    Report Date
    September 19, 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

    E1: PATIENT CITY:(B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES.

    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: 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 18/SEP/2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6001424". THE COUNT OF COMPLAINT IS 6 WHICH IS EXCEEDS 3. FURTHER INVESTIGATION IS REQUIRED VIA CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINT NUMBERS ARE: "(B)(4)." DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001424 WAS PACKAGING ACCORDING TO WORK INSTRUCTION (WI) VERSION 75 IN THE MULTIVAC 12 ON 26/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) WAS OPENED DURING THE STERILIZATION PROCESSES ACTIONS WERE REQUIRED. THEREFORE, THE 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. TEST RESULTS: PHYSICAL SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER HAS CONFIRMED THAT NO SAMPLES ARE AVAILABLE FOR TESTING. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES, ONE NONCONFORMANCE (NC) WAS RAISED DURING THE STERILIZATION PROCESS, AND FOUND UNRELATED TO THE REPORTED MALFUNCTION CODE, THE THRESHOLDS OF 6 REPORTABLE COMPLAINTS IS MET FOR THE LOT IN QUESTION AND FINAL REPORTING DECISION "SERIOUS INJURY AND DEATH", FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CAPA DETERMINATION ASSESSMENT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE INFUSION SET PACKAGING WAS DAMAGED PRIOR TO USE. ALSO, THE PACKAGING WAS NOT SEALED PROPERLY, MISSHAPED OR STERILE PACKAGING WAS NOT INTACT. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 400 MG/DL WHICH WAS TREATED BY INSULIN PEN. 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
    1294371 MINMED 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