BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19640290 · Received June 29, 2024

    Report

    Report Number
    3003442380-2024-10929
    Event Type
    Malfunction
    Date Received
    June 29, 2024
    Date of Event
    April 29, 2024
    Report Date
    November 12, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-10929. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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. PER REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DHR REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001929, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6001929 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 105 AND MANUFACTURED IN THE LINE INSET 3 ON 27-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. TUBE GLUING THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 3F03208 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC03, ON 27-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 8 OF 10.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, THE PATIENT EXPERIENCED ISSUES WITH 10 INFUSION SETS. THE SITE ISSUES REPORTED WERE OF THE SAME TYPE. THE PATIENT MENTIONED THAT THE BLOOD GLUCOSE (BG) LEVELS WERE HIGHER THAN EXPECTED AND UPON INSPECTION OF THE SITE, IT APPEARED WET WITH INSULIN, BUT NO APPARENT POINT OF LEAKAGE WAS FOUND. THE EVENT DATE WAS REPORTED TO BE WITHIN THE PAST MONTH OR SINCE 29-APR-2024. THE INFUSION SET WAS IN USE FOR 2-2.5 DAYS. THE PATIENT'S BG DUE TO THE ISSUE WAS 392 MG/DL. THE PATIENT TOOK CORRECTION BOLUS VIA PUMP AND MDI AND THEN CHANGED THE INFUSION SET. THE PATIENT RESOLVED THE ISSUE BY REPLACING THE INFUSION SET AND SUCCESSFULLY RESUMED INSULIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546839 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6001929 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female