BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 20891480 · Received December 10, 2024

    Report

    Report Number
    3003442380-2024-34104
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    October 28, 2024
    Report Date
    August 12, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 3 OF 6.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 2061952: CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MODEL NUMBER, SERIAL 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, THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. THE BATCH 6005475 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE REFERENCE SAMPLES FOR BATCH 6005475 WERE PREVIOUSLY TESTED IN COMPLAINT 2087954 ON 26/MAY/2025. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 6005475 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 111 IN THE LINE L-5, ON 17/FEB/2024, 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 DATABASEBON 07/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6005475 AND OTHER 5 COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED SIX INFUSION SET CANNULA KINKED EVENT ON 28-OCT-2024. THE EVENT OCCURRED WITHIN THREE OR MORE HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR LESS THAN 24 HOURS. THE BLOOD GLUCOSE LEVEL WAS HIGH (SPECIFIC VALUE UNKNOWN) AND THE PATIENT WAS TREATED WITH MULTIPLE DAILY INJECTION (MDI). THE PATIENT RECEIVED IV FLUIDS OF SALINE AND INSULINE AND WAS RELEASED FROM HOSPITAL ON (B)(6) 2024. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS 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
    1419302 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6005475 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female