BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19936091 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19844
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 24, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018150
    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: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: THE COMPLAINT (B)(4) HAS BEEN EVALUATED. THE LOT 6002935 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 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 WITH VERSION 41 QUALITY CRITERIA FOR INSET FAMILY PRODUCTS ENG-ESP.DOCX (CRITERIOS DE CALIDAD PARA PRODUCTOS DE LA FAMILIA INSET ENG-ESP.DOCX) - VERSION 18 ACCEPTANCE CRITERIA FOR THE SPOT CURING PROCESS.DOC TEST ON RETURNED REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO VERSION 10 FLOW TESTS IN CUSTOMER COMPLAINTS.DOC (PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE.DOC) TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO VERSION 25 INSTRUCTIONS FOR USING LEAK DETECTION EQUIPMENT IN THE INSPECTION AREA.DOC (PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE.DOC) TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. BATCH REVIEW: THE LOT 6002935 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 106 ON THE PACKING PROCESS IN THE LINE 1, ON 28/AUG/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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT, THE PATIENT FACED ISSUE OF LEAKAGE WITH INFUSION SET ON (B)(6) 2024. THE LEAKAGE WAS LOCATED AT THE TUBING, AFTER BEING IN USE FOR ONE DAY. THE BLOOD GLUCOSE LEVEL WAS 22 MMOL/L, WHICH WAS RESOLVED BY REPLACING INFUSION SET AND RESUMING INSULIN. 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
    2398722 AUTOSOFT 90 UNO INSET II 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002818 6002935 05705244018150

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male