BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19969046 · Received August 12, 2024

    Report

    Report Number
    3003442380-2024-20571
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    May 26, 2024
    Report Date
    September 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    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: H11: INVESTIGATION SUMMARY: THE COMPLAINT (B)(4) HAS BEEN EVALUATED. THE LOT 6001806 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE INCORRECT INSERTION OF THE SOFT CANNULA. COMPLAINT INVESTIGATIONS: PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WI VERSION 41 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TOWI VERSION 41 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. BATCH REVIEW THE LOT 6001806 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 105 ON THE PACKING PROCESS IN THE LINE L, ON 12/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    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 THE PATIENT NOTICED PARTIALLY INSERTED CANNULA EVENTS ON 26-MAY-2024. THE EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE INFUSION SET WAS INSERTED IN ABDOMEN. PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484987 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6001806 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male