BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 22085476 · Received May 27, 2025

    Report

    Report Number
    3003442380-2025-09962
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    April 28, 2025
    Report Date
    June 27, 2025
    Manufacturer
    UNOMEDICAL UM-D
    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

    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. THE BATCH 6010032 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE REFERENCE SAMPLES FOR THE LOT 6010032 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION AND TESTED FOR FLOW IN THE COMPLAINT (B)(4) ON 08/JUN/2025. ALL TEST RESULTS WERE FOUND WITHIN SPECIFICATIONS AS PER THE TEST REPORT COMPLAINT (B)(4) TEST REPORT.PDF ATTACHED IN THIS RECORD. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3.0 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. FUNCTIONAL AIR FLOW TEST ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010032 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 AND PACKAGING IN THE MULTIVAC 12, ON 29/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY LOT: THE LOT 4K05682 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 28/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05683 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 28/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K06592 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05698 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 02/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 4K05238 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP08, ON 26/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05680 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP05, MP08, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05113 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP08, ON 25/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 27/JUN/2025 AGAINST MALFUNCTION CODE IDD-PMC03.02 OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6010032 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON REFERENCE SAMPLES, NO ISSUE WERE FOUND RELATED TO OCCLUSION, HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINT WAS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION, NO FURTHER ACTION ARE REQUIRED, THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT THERE WAS BLOCKAGE IN THE TUBING ON (B)(6) 2025. THE PATIENT REPLACED THE SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. 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
    333669 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001680 6010032 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female