BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23739110 · Received December 8, 2025

    Report

    Report Number
    3003442380-2025-17194
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 24, 2025
    Report Date
    February 5, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017818
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 05-FEB-2026 AGAINST "LOT NUMBER 6011825 AND SIMILAR MALFUNCTION CODES: INSULIN OVERDOSING DUE TO PRIMING SET UP NOT FOLLOWED, THE REVIEW CONFIRMED THAT LOT 6011825 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 05-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6011825 AND SIMILAR MALFUNCTION CODES: INSULIN OVERDOSING DUE TO PRIMING SET UP NOT FOLLOWED. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE (B)(4) DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011825 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 AND PACKAGED IN THE MACHINE MULTIVAC 12, ON 21-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DHR REVEALED THAT DURING ON-LINE, ONE SAMPLE WAS FOUND WITH BENT NEEDLE AND OTHER SAMPLE WAS FOUND WITH EXCESS TAPE. CONSEQUENTLY, AN EXTENDED WERE RAISED. HOWEVER, ACCORDING TO THE SAMPLING RESULTS, THE LOT WAS ACCEPTED. FURTHERMORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE 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). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: 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 6011825 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.

    Additional Manufacturer Narrative · 0

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

    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 NETHERLANDS. IT WAS REPORTED THAT PATIENT EXPERIENCED EVENT OF HYPOGLYCAEMIA ON (B)(6) 2025. THE PATIENT WAS TREATED WITH GLYCOGEN PEN. THE DURATION OF HOSPITALIZATION WAS LESS THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158065 QUICK SET UNO QUICK-SET 80/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-386A 6011825 05705244017818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention