BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19936742 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19489
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 21, 2024
    Report Date
    September 24, 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 1933925 - MDR 3003442380-2024-19489 - DEVICE 3 OF 4.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-19489. 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 6003858 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 (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). 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 QUALITY CRITERIA FOR INSET FAMILY PRODUCTS ENG-ESP.DOCX - VERSION 18 ACCEPTANCE CRITERIA FOR THE SPOT CURING PROCESS.DOC (CRITERIOS DE CALIDAD PARA PRODUCTOS DE LA FAMILIA INSET ENG-ESP.DOCX) TEST ON RETURNED REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WI VERSION 10 FLOW TESTS IN CUSTOMER COMPLAINTS.DOC TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH WI VERSION 25 INSTRUCTIONS FOR USING LEAK DETECTION EQUIPMENT IN THE INSPECTION AREA.DOC (INSTRUCCIONES PARA EL USO DEL EQUIPO DE FUGA EN EL AREA DE INSPECCION.DOC) TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6003858 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 69 ON THE PACKING PROCESS IN L149, ON 25/OCT/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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS LEAKAGE EVENTS ON 21-JUNE-2024, AND 24-JUNE-2024. THE INFUSION SET WAS IN USE FOR 2 HOURS. BLOOD GLUCOSE LEVELS REPORTED DURING THE EVENT WAS 300 MG/DL. PATIENT RESOLVED IT BY REPLACING INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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
    1025964 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003858 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female