BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24510838 · Received March 4, 2026

    Report

    Report Number
    3003442380-2026-00684
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    July 13, 2024
    Report Date
    February 5, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: UNITED STATES. UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CAPA/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED BASED ON THE REVIEW COMPLETED ON 05-FEB-2026 AND INVESTIGATION COMPLETED ON 05-FEB-2026 THIS MDR IS BEING SUBMITTED AS THE INITIAL REPORT. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 04-FEB-2026 AGAINST "LOT NUMBER 6003854 AND SIMILAR MALFUNCTION CODE(S): NON PRODUCT RELATED EVENT DUE TO PRIOR CLINICAL CIRCUMSTANCES, IMPROPER PRODUCT SELECTION/TREATMENT METHOD, ACCORDING TO CLINICAL HISTORY OF THE COSTUMER (E.G., HISTORY OF ALLERGIC REACTIONS, CONTINUING USE DESPITE KNOWN ISSUE(S) WHEN USING THE SET), CLINICAL HISTORY - NON-PRODUCT EVENT, THE REVIEW CONFIRMED THAT LOT 6003854 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 04-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6003854 AND SIMILAR MALFUNCTION CODES NON PRODUCT RELATED EVENT DUE TO PRIOR CLINICAL CIRCUMSTANCES, IMPROPER PRODUCT SELECTION/TREATMENT METHOD, ACCORDING TO CLINICAL HISTORY OF THE COSTUMER (E.G., HISTORY OF ALLERGIC REACTIONS, CONTINUING USE DESPITE KNOWN ISSUE(S) WHEN USING THE SET), CLINICAL HISTORY - NON-PRODUCT EVENT. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE COMPLAINT: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003854 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND PACKAGED IN THE MACHINE MULTIVAC 12, ON 23-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. RETAIN SAMPLES TESTING: BASED ON THE CLASSIFICATION OF THE MALFUNCTION CODE, THIS TYPE OF ISSUE DOES NOT REQUIRE VISUAL TESTING, FUNCTIONAL TESTING, OR EVALUATION OF RETAIN SAMPLES, AS IT CORRESPONDS TO CATEGORIES SUCH AS "MISUSE, USER RELATED ISSUES, OR NO MALFUNCTION ALLEGED." THEREFORE, NO RETAIN SAMPLES WERE REQUESTED AND NO PRODUCT TESTING WAS PERFORMED. CONCLUSION: NO RETAIN SAMPLES WERE REQUESTED AND NO PRODUCT TESTING WAS PERFORMED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). AS A RESULT OF THE FOLLOWING A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6003854 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO RETAIN SAMPLES WERE REQUESTED AND NO PRODUCT TESTING WAS PERFORMED, BASED ON THE CLASSIFICATION OF THE MALFUNCTION CODE, THIS TYPE OF ISSUE DOES NOT REQUIRE VISUAL TESTING, FUNCTIONAL TESTING, OR EVALUATION OF RETAIN SAMPLES, AS IT CORRESPONDS TO CATEGORIES SUCH AS "MISUSE, USER RELATED ISSUES, OR NO MALFUNCTION ALLEGED. SO, THE ASSESSMENT WAS BASED ON DOCUMENTATION. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING. FOR MORE DETAILS, SEE THE INFORMATION UNDER THE CHILD INVESTIGATION RECORD (B)(4).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT GOT HOSPITALIZED ON (B)(6) 2024 DUE TO HIGH BLOOD GLUCOSE (BG) LEVELS 400 MG/DL EVENT. PATIENT ALSO HAD MEMORY PROBLEMS THAT LED TO MISSED BOLUSES, DOUBLE DOSING, AND INCONSISTENT INSULIN DELIVERY. PATIENT PASSED AWAY DUE TO HIGH BG AND LOW BG ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567671 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6003854 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death