BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20046502 · Received August 23, 2024

    Report

    Report Number
    3003442380-2024-22099
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 5, 2024
    Report Date
    October 30, 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

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

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4). 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 COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6002595 IN QUESTION WAS MANUFACTURED AT THE (B)(4) SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WORK INSTRUCTIONS (WI) 3802038 GUIDELINE FOR TEST OF REFERENCE SAMPLES VERSION 11 FOR THE CODE IDD-PMC02.02 LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE) 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 WI 4902148 VERSION 43, 4A02025 VERSION18 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WI 4802011 VERSION 10 TEST ON RETURNED. UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH (B)(4) VERSION 25 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6002595 WAS MANUFACTURED ACCORDING TO THE DOCUMENT (B)(4) VERSION 68 ON THE PACKING PROCESS IN THE MACHINE L158, ON 03/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY REPORT (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 NC RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET LEAKING AT SITE EVENT ON 24-JUN-2024, 29-JUN-2024, 05-JUL-204 AND 13-JUL-2024. THE GLUCOSE LEVEL WAS HIGH (SPECIFIC VALUE UNKNOWN) AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. 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
    1698575 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6002595 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female