BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19590460 · Received June 21, 2024

    Report

    Report Number
    3003442380-2024-09669
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    March 15, 2024
    Report Date
    August 7, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244021099
    PMA / PMN Number
    K032854
    Adverse Event
    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 AND EXPIRATION DATE UNDER D4. 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: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED. THE BATCH 6002638 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002638 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 AND MANUFACTURED IN THE LINE INSET 5, ON 09/AUG/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 06/AUG/2025 AGAINST MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED, HARM CODE UNTREATED DIABETIC KETOACIDOSIS OR ISOLATED ELEVATED BLOOD GLUCOSE WHICH THE PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY AN HEALTH CARE PROFESSIONAL (HCP) OR REQUIRES EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT PERMANENT ORGAN DAMAGE (ELEVATED BLOOD GLUCOSE LEVEL, PRESENCE OF KETONES AND SYMPTOMS E.G., NAUSEA, VOMITING, ABDOMINAL PAIN, CONFUSION) AND LOT 6002638 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR 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. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET HAD OCCLUSION ALARM ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS 800 - 900 MG/DL AT THE TIME OF EVENT AND PATIENT WAS HOSPITALIZED DUE TO THAT EVENT. THE PATIENT HAD HIGH KETONES ALSO. 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
    164664 AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US FPA UNOMEDICAL A/S 1003912 6002638 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Hospitalization| R