BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FLEXLINK ULTRAFLEX (ACCU-CHEK)

    MDR report key: 24965905 · Received April 23, 2026

    Report

    Report Number
    3003442380-2026-83844
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 26, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL 2 OF 2 E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: BRAZIL. NAME: (B)(6). IMDRF CAUSE INVESTIGATION CODE: CODE B24 IS NOT AVAILABLE IN DATABASE TO CAPTURE EVENT HISTORY LOG REVIEW COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 09-APR-2026 AGAINST LOT NUMBER 6001069 AND SIMILAR MALFUNCTION CODES: INFUSION SITE LEAKAGE ¿ TRACE MOISTURE / SUPERFICIAL WETNESS, LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA). (SPECIFIC CAUSE NOT IDENTIFIED). THE REVIEW CONFIRMED THAT LOT 6001069 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 09-APR-2026 AGAINST ¿LOT NUMBER¿ CRITERIA EQUAL 6001069 AND SIMILAR MALFUNCTION CODES: INFUSION SITE LEAKAGE ¿ TRACE MOISTURE / SUPERFICIAL WETNESS. LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA). THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR)REVIEW: THE LOT 6001069 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 43 AND PACKAGING IN THE MULTIVAC 07, ON 15-APR-2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE CANNULA LOT 3D00046 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN LINE 2, ON 12-APR-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: RETAIN SAMPLES FROM THE RELEVANT LOT WERE REQUESTED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA (VERSION 3): ALL SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA (VERSION 2): ALL SAMPLES TESTED PASSED FUNCTIONAL FLOW AND LEAK TESTS FOR THE REPORTED MALFUNCTION CODE INFUSION SITE LEAKAGE ¿ TRACE MOISTURE / SUPERFICIAL WETNESS. ALL TEST RESULTS WERE PREVIOUSLY TESTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4) TEST REPORT. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. 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 A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6001069 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. BASED ON THE DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. 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

    IT WAS REPORTED THAT THE INSULIN LEAKAGE WITH TWO INFUSION SETS ON (B)(6) 2026 AND THE SITE OF INSERTION WAS ABDOMEN. THE PATIENT WAS EXPERIENCED HIGH BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64281 FLEXLINK ULTRAFLEX (ACCU-CHEK) SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 04626435001 6001069

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female