BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19342567 · Received May 17, 2024

    Report

    Report Number
    3003442380-2024-02493
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Report Date
    September 26, 2024
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6002060 IN QUESTION WAS MANUFACTURED AT THE OSTED 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 MALFUNCTION 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 HAVE BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WI VERSION 15 QUALITY SPECIFICATION - INSET GUARD RAMP-UP & INSET GUARD EWIS. TEST ON RETURNED REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WI VERSION 10 FLOW TEST ON CUSTOMER COMPLAINTS -PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE.DOC. TEST ON RETURNED REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH WI VERSION 25 INSTRUCCIONES PARA EL USO DEL EQUIPO DE FUGA EN EL AREA DE INSPECCION.DOC. TEST ON RETURNED REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6002060 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 14 ON THE PACKING PROCESS IN THE MACHINE SL01 / LINE MV11, ON 01/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 NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    MDR 3003442380-2024-02493 - DEVICE 10 OF 10.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED SATES IT WAS REPORTED THAT PATIENT FACED AN ISSUE WITH MORE THAN TEN INFUSION SET TUBING WAS LEAKING AT SITE. THE BLOOD GLUCOSE LEVEL WAS 250 MG/DL AT THE TIME OF INCIDENT. THE INFUSION SET WAS IN USE FOR ONE TO TWO DAYS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500484 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA 5359487 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown