BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19571223 · Received June 19, 2024

    Report

    Report Number
    3003442380-2024-08900
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 10, 2024
    Report Date
    December 2, 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 MODEL NUMBER AND SERIAL NUMBER 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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003222 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR)REVIEW: THE LOT 6003222 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 AND MANUFACTURED IN THE LINE 8 ON 13/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3J00371 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC09, ON 10/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DHR REVEALED THAT DURING ON-LINE TEST 5, ONE SAMPLE WAS WITH INCORRECTLY SEALING ON THE TYVEK. CONSEQUENTLY, AN EXTENDED FOR THIS ISSUE WAS RAISED. HOWEVER, ACCORDING TO THE SAMPLING RESULTS, THE LOT WAS ACCEPTED. FURTHERMORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: THE DHR REVIEW IDENTIFIED MINOR FINDINGS. THEY WERE MANAGED ACCORDING TO PROCEDURE AND DID NOT IMPACT COMPLIANCE. NO NON-CONFORMITIES (NC) WERE RECORDED IN CONNECTION WITH THE MALFUNCTION CODE REPORTED IN THE COMPLAINT, 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

    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. ON (B)(6) 2024, IT WAS REPORTED THAT THE INFUSION SET TUBING DETACHED FROM CONNECTOR, WHICH CAUSED THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED TO 323 MG/DL. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378875 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003222 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization