BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19672702 · Received July 3, 2024

    Report

    Report Number
    3003442380-2024-11718
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 23, 2024
    Report Date
    October 27, 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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, 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 6003538, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6003538 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 108 AND MANUFACTURED IN THE LINE 7 ON 08-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCES NC WAS RAISED DUE TO MANUFACTURING PROCESS. THIS NC IS NOT RELATED TO CLAIMED MALFUNCTION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: ONE NONCONFORMANCE (NC) WAS RAISED RELATED TO THE MANUFACTURING PROCESS, AND FOUND UNRELATED TO THE REPORTED MALFUNCTION 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.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024 IT WAS REPORTED THAT THE ONE INFUSION SET CANNULA WAS BROKEN AT A 90 DEGREE ANGLE AND PATIENT FACES SYMPTOMS WITHIN 3 OR MORE HOURS AFTER INSERTION AND INFUSION SET IS LONG FOR LESS THAN A DAY. THE BLOOD GLUCOSE LEVEL WAS 350 MG/DL. NO FURTHER INFORMATION 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
    436144 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003538 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male