BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 19916088 · Received August 6, 2024

    Report

    Report Number
    3003442380-2024-19064
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    January 10, 2024
    Report Date
    January 11, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    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. INVESTIGATION SUMMARY: THE FOLLOWING TESTS WERE COMPLETED FOR 10 REFERENCE SAMPLES OF LOT 5408101: 1. VISUAL INSPECTION AS PER 4902138 (CRITERIOS DE CALIDAD PARA PRODUCTOS DE LA FAMILIA CONTACT) QUALITY CRITERIA FOR CONTACT FAMILY PRODUCTS, VERSION 10. 10 SAMPLES VISUALLY INSPECTED AND NO DEVIATIONS IDENTIFIED. 2. 4802011, FLOW TEST ON CUSTOMER COMPLAINTS (PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE), VERSION 10.10 SAMPLES TESTED AND NO DEVIATIONS VALUE TEST P1.- 148 P2.- 220, P3.- 136, P4.- 209, P5.-204, P6.-49, P7.-138, P8.-173, P9.-207, P10.-117. 3. 4802101, LEAK TEST ON CUSTOMER COMPLAINTS (PRUEBAS DE FUGA EN QUEJAS DEL CLIENTE), VERSION 44. 10 SAMPLES LEAK TESTED AND NO DEVIATIONS IDENTIFIED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT, PATIENT FACED INFUSION SET LEAKAGE ISSUE RESULTING THE BLOOD GLUCOSE LEVEL TO RISE AT 448 MG/DL. THE ACETONE LEVEL WERE AT 0.8 ALONG WITH THIRST SYMPTOMS, ABDOMINAL PAIN AND HEADACHES ON REMOVAL OF HEMATOMA. 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
    1841509 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 5408101 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown