BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19604909 · Received June 25, 2024

    Report

    Report Number
    3003442380-2024-10120
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    April 22, 2024
    Report Date
    September 24, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    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 1896136 - DEVICE 1 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-10120. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE COMMON DEVICE NAME UNDER D2A, MODEL NUMBER, SERIAL NUMBER, PRIMARY UDI NUMBER UNDER D4. 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 6003253 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORKSTATION (WI). GUIDELINE FOR TEST OF REF. SAMPLES VERSION 11 FOR THE CODE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED). 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 TO WITH WI VERSION 10 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH WI VERSION 25 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6003253 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 106 ON THE PACKING PROCESS IN THE LINE 5, ON 15/SEP/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, AND NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, THE PATIENT REPORTED THAT THE INFUSION SET WAS LEAKING, AROUND THE SECOND DAY OF INSERTION. THE INSERTION SITE OF THE INFUSION SITE WAS AT ABDOMEN. THE INSERTION SITE WAS CHANGED EVERY 3 DAYS. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS ABOVE 200-250MG/DL. 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
    1280809 AUTOSOFT XC INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 6003253 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male