BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20975188 · Received December 19, 2024

    Report

    Report Number
    3003442380-2024-34521
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 11, 2024
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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). 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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6000621 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000621 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 104 AND MANUFACTURED IN THE LINE 5 ON 29/MAY/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3E03335 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC04, ON 28/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3E05259 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC04, ON 30/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3E03207 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC04, ON 28/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE DHR REVIEW INDICATED THAT DURING ON-LINE TEST 3, TWO SAMPLES WERE FOUND WITH THE MISALIGNED SLEEVE DUE TO THIS A LOG23-091 WAS OPENED DURING THE RELATED PROCESSES AND FURTHER PRODUCT DISPOSITION WERE REQUIRED. HOWEVER, 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 1 OF 5.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS TUBE DETACHED FROM CONNECTOR. TWO EVENTS OCCURRED ON (B)(6) 2024, OTHER TWO EVENTS OCCURRED ON (B)(6) 2024, AND ONE EVENT OCCURRED ON (B)(6) 2024. TWO INFUSION SETS WERE USED FOR 3 HOUR, OTHER TWO INFUSION SETS WERE USED FOR OVER THREE HOURS, AND ONE INFUSION SET WAS USED FOR OVER THREE HOURS. THE BLOOD GLUCOSE LEVEL WAS 371 MG/DL. HIGH BLOOD GLUCOSE LEVEL WAS ADDRESSED WITH A CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547469 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6000621

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male