BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19926996 · Received August 7, 2024

    Report

    Report Number
    3003442380-2024-19347
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    January 8, 2024
    Report Date
    August 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 1933076 - MDR 3003442380-2024-19347. 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 WERE VISUALLY INSPECTED TO THE TAPE. 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 .DOC BATCH REVIEW: THE BATCH LISTED IN THE TRACKWISE COMPLAINT PARENT RECORD WAS REVIEWED AND CONFIRMED TO BE ACCURATE. UNO CONTACT DETACH G29 60/6TCAP 10PK INT WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1726019 AND MANUFACTURING LOT NUMBER 6004899 ON 09-JAN-2024 AND 30,000 FINAL UNITS IN THE MACHINE 14 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 PATIENT FACED SIX INFUSION SETS FELL OFF EVENTS WHILE DOING SWIMMING ON DATE (B)(6) 2024. FIRST INFUSION SET WAS IN USE FOR 1 HOUR. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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
    580758 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6004899 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male