BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSTEEL

    MDR report key: 22093813 · Received May 28, 2025

    Report

    Report Number
    3003442380-2025-09551
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    April 28, 2025
    Report Date
    June 5, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    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. H11: INVESTIGATION SUMMARY: THE REFERENCE SAMPLES FOR THE LOT 6010012 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL AND FLOW IN THE (B)(4) ON 07/MAY/2025. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER (B)(4)TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: PACKAGING LOT: THE LOT 6010012 WAS PACKAGING ACCORDING TO THE WORK INSTRUCTION (WI) VERSION (B)(4), IN THE MACHINE MULTIVAC (B)(4), ON 10/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 4K02983 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65, IN THE MACHINE SC05 AND SC06, ON 06/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05301 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65, IN THE MACHINE SC08, ON 07/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-CONNECTOR LOT: THE LOT 4K02897 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37, IN THE MACHINE MP03, ON 31/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K02898 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37, IN THE MACHINE MP03, ON 01/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K02899 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37, IN THE MACHINE MP03, ON 01/NOV/2024, WITH A TOTAL OF (B)(4) UNITS REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 04-JUN-2025 AGAINST MALFUNCTION CODE OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). AND LOT 6010012 AND NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINTS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT TOOK PLACE IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON 28-APR-2025. THE BLOOD GLUCOSE LEVEL WAS EXCEED 500 MG/DL AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729670 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL UM-D 1002833 6010012 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown