BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 24206986 · Received January 29, 2026

    Report

    Report Number
    3003442380-2026-00172
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 30, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019317
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 29-JAN-2026 AGAINST "LOT NUMBER" "6014069" AND SIMILAR MALFUNCTION CODES: OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED, CANNOT BE DETERMINED. NO ESCALATION REQUIRED, OCCLUSION ISSUES-CANNOT BE DETERMINED. THE REVIEW CONFIRMED THAT LOT 6014069 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 29-JAN-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6014069" AND SIMILAR MALFUNCTION CODES: OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED. NO ESCALATION REQUIRED, OCCLUSION ISSUES-CANNOT BE DETERMINED. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6014069 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MULTIVAC 14, ON 05-JUL-2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE WELDING LOT 5G00145 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINES LS25 & LS24, ON 03-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE WELDING LOT 5F04179 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINES LS06 & LS07, ON 01-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE WELDING LOT 5G01356 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINES LS25 & LS24, ON 05-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR OF THE LOT 5F03949 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 3, ON 02-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR OF THE LOT 5F03950 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 3, ON 02-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR OF THE LOT 5F03951 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 3, ON 04-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR OF THE LOT 5F03948 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 3, ON 05-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR OF THE LOT 5F03952 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 3, ON 05-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR OF THE LOT 5F03956 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 3, ON 07-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5F04737 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE MACHINE FT02, ON 05-JUL-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5F04735 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE MACHINE FT02, ON 22-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5F04736 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE MACHINE FT02, ON 04-JUL-2025, 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 3 SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION OCCLUSION ISSUES-CANNOT BE DETERMINED. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED COMPLAINT (B)(4) TEST REPORT. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. RETURN SAMPLES TESTING: RETURNED SAMPLES FROM THE RELEVANT LOT WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. CONCLUSION: VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO LACK OF SAMPLE AVAILABILITY. ASSESSMENT WILL BE BASED ON OTHER AVAILABLE EVIDENCE. 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 6014069 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS 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.

    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 BELGIUM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSULIN FLOW BLOCKED ALARM WITH INSULIN DELIVERY LEADING TO HIGH BLOOD GLUCOSE LEVEL EVENT ON (B)(6) 2026. THE PATIENT WAS TREATED WITH INSULIN PEN INJECTION AND WENT TO EMERGENCY ROOM (ER) AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL WITH SYMPTOMS LIKE FEELING UNWELL ON (B)(6) 2026, WITH A LENGTH OF HOSPITALIZATION LESS THAN TWENTY-FOUR HOURS, DUE TO HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVEL WHEN ADMITTED TO HOSPITAL WAS 470MG/DL. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH INSULIN INJECTIONS MANUALLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270884 CONTACT DETACH UNO CONTACT DETACH G29 60/6 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-864A 6014069 05705244019317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown