BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 24614788 · Received March 17, 2026

    Report

    Report Number
    3003442380-2026-02137
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 21, 2026
    Report Date
    May 5, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K991759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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 04/MAY/2026 AGAINST "LOT NUMBER" "6012929" AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO ADHESIVE PATCH ANOMALY. ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE), ADHESIVE PATCH PARTIALLY LIFTS DURING USE - TRACE MOISTURE / MINOR WETNESS. THE REVIEW CONFIRMED THAT LOT 6012929 WAS ASSOCIATED WITH NON-CONFORMANCE (NC)-2214182 FOR TEMPERATURE PARAMETER OUT OF SPECIFICATION. HOWEVER, THIS NON-CONFORMANCE (NC) IS NOT RELATED TO THE REPORTED FAILURE MODE AND IS NOT ASSOCIATED WITH ANY NCS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 04/MAY/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6012929" AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO ADHESIVE PATCH ANOMALY. ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE), ADHESIVE PATCH PARTIALLY LIFTS DURING USE - TRACE MOISTURE / MINOR WETNESS. THE COUNT OF COMPLAINTS IS 2. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012929 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC12, ON 27/APR/2025 WITH A TOTAL OF (B)(4) UNITS. SUB-ASSEMBLY: ASSEMBLY THE SUB-ASSEMBLY OF THE LOT 5D01276 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN QUICKSET LINE, ON 26/APR/2025, WITH A TOTAL OF (B)(4) UNITS THE SUB-ASSEMBLY OF THE LOT 5D01277 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN QUICKSET LINE, ON 26/APR/2025, WITH A TOTAL OF (B)(4) UNITS THE REVIEW CONFIRMED THAT LOT 6012929 WAS ASSOCIATED WITH NON-CONFORMANCE (NC) 2214182, WHICH INVOLVED TEMPERATURE PARAMETERS OUT OF SPECIFICATION. ADDITIONALLY, A REVIEW OF THE DHR SHOWED THAT DURING THE OUTGOING TEST 6 AN EXTENDED WAS FOUND FOR CONTAMINATION BY A FOREIGN OBJECT IN THE INFUSION SET IN ONE SAMPLE IN LOT 6012929 AND THEREFORE THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. HOWEVER, THIS NONCONFORMANCE IS NOT RELATED TO THE REPORTED FAILURE MODE AND IS NOT ASSOCIATED WITH ANY NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE. 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. CAPA DETERMINATION ASSESSMENT - 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). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. 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 6012929 AND RELATED MALFUNCTION CODES. TWO COMPLAINTS WERE IDENTIFIED FOR THIS LOT, BUT 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 PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 8021545. MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET TAPE NOT STICKING EVENT ON 21-FEB-2026. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433513 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6012929 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1