BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 24319652 · Received February 11, 2026

    Report

    Report Number
    3003442380-2026-00566
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    November 27, 2023
    Report Date
    January 21, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A 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 21-JAN-2026 AND INVESTIGATION COMPLETED ON 24-JAN-2026 THIS 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 COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 13-JAN-2026 AGAINST "LOT NUMBER 6001669 AND SIMILAR MALFUNCTION CODE(S): INSERTION INTO SCAR TISSUE,IMPROPER SITE SELECTION, OR INCORRECT PREPARATION OF SET, SET BROKE PRIOR TO USE DUE TO INSERTION INTO SCAR TISSUE, INTO SITES NOT STATED BY THE IFU, OR INCORRECT PREPARATION OF SET. THE REVIEW CONFIRMED THAT LOT 6001669 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 13-JAN-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6001669 AND SIMILAR MALFUNCTION CODES INSERTION INTO SCAR TISSUE,IMPROPER SITE SELECTION, OR INCORRECT PREPARATION OF SET, SET BROKE PRIOR TO USE DUE TO INSERTION INTO SCAR TISSUE, INTO SITES NOT STATED BY THE IFU, OR INCORRECT PREPARATION OF SET., THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001669 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 63 AND MANUFACTURED IN THE LINE INSET 6 ON 13-JUL-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 PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 09/OCT/2023. WI - GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 3 SAMPLES OUT 3 TESTED PASSED VISUAL INSPECTION. WI - GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE, NO MALFUNCTION BASED ON COMPLAINT INFORMATION WI - GUIDANCE FOR FUNCTIONAL TESTING 2 AIR LEAK TEST FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE, NO MALFUNCTION BASED ON COMPLAINT INFORMATION CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. 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 WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). 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 6001669 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. SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO SAMPLES WERE AVAILABLE FOR ANALYSIS. CONSEQUENTLY, AN INVESTIGATION WAS CONDUCTED USING REFERENCE SAMPLES, AND NO FAILURES RELATED TO THE COMPLAINT WERE IDENTIFIED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING. FOR MORE DETAILS, SEE THE INFORMATION UNDER THE CHILD INVESTIGATION RECORD (B)(4).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 TO (B)(6) 2023 AND EVENTUALLY SHIFTED TO INTENSIVE CARE UNIT (ICU) DUE TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 45MMOL/L. THE PATIENT GOT TREATED WITH POTASSIUM AND INSULIN INFUSION. THE CAUSE OF HYPERGLYCEMIA IS DUE INFUSION SET WAS NOT POSITIONED CORRECTLY INTO THE SKIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377194 INSET II UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL UM-D 86-060-52B6 6001669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization