BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19957189 · Received August 10, 2024

    Report

    Report Number
    3003442380-2024-20661
    Event Type
    Malfunction
    Date Received
    August 10, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018457
    PMA / PMN Number
    K041545
    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. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) VERSION 11. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES 10/10 WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION ACCORDING TO VERSION. 17 SAMPLE OF THE CONTACT DETACH, NERIA MULTI, AND TRUSTEEL MODELS - SAMPLER FOR CONTACT, CONTACT DETACH, NERIA MULTI DOCUMENT FUNCTIONAL TEST 1: (VERSION.9) QUALITY SPECIFICATION DOCUMENT FOR THE FLOW TEST OF STEEL PRODUCTS BATCH REVIEW: THE BATCH LISTED IN THE TRACKWISE COMPLAINT PARENT RECORD WAS REVIEWED AND CONFIRMED TO BE ACCURATE. UNO CONTACT DETACH G29 80/6TCAP 10PK INT WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1726021 AND MANUFACTURING LOT NUMBER 6003196 ON 07-SEP-2023. 30,000 FINAL UNITS IN THE MACHINE 10 WERE MANUFACTURED. THE BATCH RECORD CONFIRMS THIS INFORMATION. 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED OCCLUSION AT INFUSION SET TUBING EVENT ON 01-JUL-2024.THE BLOOD GLUCOSE LEVEL WAS 450 MG/DL AT THE TIME OF EVENT THEREFORE, THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION WAS 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
    2200487 TRUSTEEL UNO CONTACT DETACH G29 80/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002834 6003196 05705244018457

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female