BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 24701471 · Received March 26, 2026

    Report

    Report Number
    3003442380-2026-99967
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    November 14, 2023
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: CZECH REPUBLIC. UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (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 25-FEB-2026 AND INVESTIGATION COMPLETED ON 12-MAR-2026, THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. 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. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6000945 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS. THIS INVESTIGATION HAS BEEN UPDATED BECAUSE THE MALFUNCTION CODE CHANGED, WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 15-NOV-2023. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, THE FOLLOWING ELEMENTS WERE ADDED TO ALIGN WITH CURRENT INVESTIGATION REQUIREMENTS: COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 12/MAR/2026 AGAINST "LOT NUMBER" "6000945" AND SIMILAR MALFUNCTION CODES: INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS, LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED). THE REVIEW CONFIRMED THAT LOT 6000945 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON CONFORMANCE REPORT (NCR)S OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 12/MAR/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6000945" AND SIMILAR MALFUNCTION CODES: INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS, LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED). THE NUMBER OF COMPLAINTS IS 2. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000945 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 14 AND MANUFACTURED IN THE M10 AND M14, ON 06/MAY/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: CANNULA LOT 3E00791 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 03-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3D01364 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 03-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3D01362 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC04, ON 01-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3E01139 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 08-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT DURING THE OUTGOING TEST #9 AN EXTENDED WAS FOUND FOR LAMINATED TAPE IN TWO SAMPLE IN LOT 6000945 AND THEREFORE THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO 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. 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 (B)(4) (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CZECH REPUBLIC. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON 14-NOV-2023. THE LEAKAGE WAS AT THE SITE. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765914 COMFORT UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-381A 6000945 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown