BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19838583 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16660
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    April 24, 2024
    Report Date
    January 24, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244021099
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 2 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) MDR 3003442380-2024-16660. 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. THE REFERENCE SAMPLES FOR THE LOT 6004237 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE (B)(4) ON 24/JAN/2025. THE REFERENCE SAMPLES WERE INSPECTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6004237 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 108 MANUFACTURED IN THE LINE 7, ON 15/NOV/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, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN TW ON 24/JAN/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6004237 AND ANOTHER 3 COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6004237 AND MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET CANNULA KINKED EVENT ON 24-APR-2024. THE PATIENT NOTICED SYMPTOMS WITHIN THREE HOURS OR MORE HOURS OF INSERTION. INFUSION SET HAD BEEN IN USE FOR LESS THAN 3HRS FOR FIRST EVENT AND 4HR FOR SECOND EVENT. INSERTION SITE WAS ABDOMEN. PATIENT REGULARLY ROTATED SITE LOCATION. FURTHERMORE, PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. BLOOD GLUCOSE LEVEL WAS NOTICED 112-358 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. UNOMEDICAL 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
    1776000 AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US FPA UNOMEDICAL A/S 1003912 6004237 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female