BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 21630200 · Received March 18, 2025

    Report

    Report Number
    3003442380-2025-03887
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    February 3, 2025
    Report Date
    January 23, 2026
    Manufacturer
    UNOMEDICAL UM-D
    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 3. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2025-03887. UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL 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 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 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: A COMPLAINT INVESTIGATION WAS CONDUCTED BASED ON THE EVENT DESCRIPTION AND THE ASSIGNED MALFUNCTION CODE - SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL (BLOCKAGE). ADDITIONAL INFORMATION WAS REQUESTED TO SUPPORT THE INVESTIGATION; HOWEVER, A LOT NUMBER INFORMATION WAS NOT PROVIDED. NO DEVICE, DEVICE COMPONENTS, OR OTHER VISUAL OR PHYSICAL EVIDENCE WAS MADE AVAILABLE FOR EVALUATION. CONSEQUENTLY, VISUAL INSPECTION, RETAIN-SAMPLE TESTING, OR THE ASSESSMENT OF POTENTIAL PRODUCT PERFORMANCE ISSUES, COMPONENT INTEGRITY, OR MANUFACTURING DEFECTS COULD NOT BE PERFORMED. IN RESPONSE TO THE COMPLAINT AND DUE TO THE ABSENCE OF A SPECIFIC LOT NUMBER, A HIGH LEVEL INVESTIGATION WAS CONDUCTED FOR THE AUTOSOFT XC PRODUCT FAMILY AND THE ASSIGNED MALFUNCTION. THE INVESTIGATION ENCOMPASSED AN ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH, ASSESSMENT OF COMPLAINT TRENDS, AND THE REVIEW OF RISK MANAGEMENT FILES. NO SYSTEMIC ISSUES WERE IDENTIFIED. PLEASE REFER TO THE ATTACHED MEMO FOR FULL DETAILS: AUTOSOFT XC_CANNULA_ ENCLOSURE 1: EQMS SEARCH RESULTS . ENCLOSURE 2: MAINTENANCE RESULTS . ENCLOSURE 3: RAW DATA FOR COMPLAINT TRENDING . CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION. BASED ON THE INVESTIGATION, NO FURTHER ACTION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. COMPLAINT INVESTIGATION - CONCLUSION. DUE TO THE ABSENCE OF A LOT NUMBER AND RETURNED PRODUCT, THE INVESTIGATION WAS LIMITED TO A HIGH LEVEL REVIEW OF THE AUTOSOFT XC PRODUCT FAMILY, INCLUDING AN EQMS SEARCH, COMPLAINT TRENDING, AND REVIEW OF APPLICABLE RISK MANAGEMENT DOCUMENTATION. NO EVIDENCE OF A SYSTEMIC ISSUE WAS IDENTIFIED. NO FURTHER ACTION IS REQUIRED AT THIS TIME, AND THE RECORD WILL BE CLOSED WITH CONTINUED MONITORING THROUGH ROUTINE TRACKING AND TRENDING. THE RECORD MAY BE REASSESSED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET CANNULA KINKED WITHIN THREE HOURS AFTER INSERTION AT RIGHT AND LEFT THIGHS AND ARMS ON (B)(6) 2025, WHICH RESULTED IN ELEVATED BLOOD GLUCOSE (OVER 488 MG/DL), THEREFORE PATIENT HAD RECEIVED CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI). IT WAS ALSO REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM AND SUBSEQUENTLY GOT HOSPITALIZED AND STAYED IN EMERGENCY ROOM FOR FOUR HOURS ON (B)(6) 2025 AND RECEIVED IV (INTRAVENOUS) AND FLUIDS OF SALINE AND INSULIN. THE INFUSION SET WAS IN USE FOR TWO HOURS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS AVAILABLE.

    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
    582666 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001680 UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention