BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19997676 · Received August 16, 2024

    Report

    Report Number
    3003442380-2024-21466
    Event Type
    Injury
    Date Received
    August 16, 2024
    Date of Event
    July 2, 2024
    Report Date
    February 12, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 1 OF 2

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 (B)(4) - MDR 3003442380-2024-21466. 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6003580 IN QUESTION WAS PRODUCED AT THE REYNOSA SITE. A DETAILED INVESTIGATION OF THE TESTING ON REFERENCE SAMPLES CANNOT BE PERFORMED. THE COMPLAINT INVESTIGATION PROCESS WAS CONDUCTED IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDELINE FOR TEST OF REF. SAMPLES VERSION 11 FOR THE CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, NO TESTING IS REQUIRED. BATCH REVIEW THE BATCH LISTED IN THE PARENT COMPLAINT RECORD WAS REVIEWED AND CONFIRMED TO BE ACCURATE. DEVICE WAS MANUFACTURED WITH SAP CODE 1722083 AND MANUFACTURING BATCH NUMBER 6003580 ON 15-OCT-2023, WITH (B)(4) FINAL UNITS MANUFACTURED. THE BATCH RECORD REVIEW WAS COMPLETED, AND NO DISCREPANCIES WERE FOUND. ALL SAMPLES FROM THE ONLINE INSPECTIONS WERE SATISFACTORY. THE BATCH RECORD CONFIRMS THIS INFORMATION. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO HARM WAS REPORTED, NO MALFUNCTION OF THE INFUSION SET WAS REPORTED, AND AS THE BATCH RECORD REVIEW YIELDED NO DISCREPANCIES, NO NON-CONFORMANCE (NC) WAS GENERATED DURING PRODUCTION.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 3003442380-2024-21466. UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL 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 SUPPLEMENTAL 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. ADDITIONAL INFORMATION - THIS MEDICAL DEVICE REPORT (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 11/FEB/2026 AGAINST "LOT NUMBER" "6003580" AND SIMILAR MALFUNCTION CODES: PATIENT-DEVICE INCOMPATIBILITY/ BIOCOMPATIBILITY-PROBLEM THE REVIEW CONFIRMED THAT LOT 6003580 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 11/FEB/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6003580" AND SIMILAR MALFUNCTION CODES: PATIENT-DEVICE INCOMPATIBILITY/ BIOCOMPATIBILITY-PROBLEM THE COUNT OF COMPLAINTS IS 2. THE COMPLAINT NUMBER IS COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003580 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 108 AND MANUFACTURED IN THE LINE 3, ON 15/OCT/2023 WITH A TOTAL OF (B)(4) UNITS. THE 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. CORRECTIVE AND PREVENTIVE ACTION (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 6003580 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. 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 THE UNITED STATES. THIS MDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF DEVICES IN WHICH THE ISSUE WAS EXPERIENCED. ON (B)(6) 2024, PATIENT ENCOUNTERED HIGH BLOOD GLUCOSE. THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE FOR 6 - 7 HOURS. THE BLOOD GLUCOSE LEVEL WAS REPORTED 400 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303254 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003580 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| H