BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSTEEL

    MDR report key: 19495147 · Received June 9, 2024

    Report

    Report Number
    3003442380-2024-07376
    Event Type
    Injury
    Date Received
    June 9, 2024
    Date of Event
    April 11, 2024
    Report Date
    August 2, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018488
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED. THE BATCH 6001679 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001679 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 43 PACKAGING IN THE LINE FLEXSET, ON 06/JUL/2023, 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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 01/AUG/2025 AGAINST MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED, HARM CODE UNTREATED DIABETIC KETOACIDOSIS WHICH THE PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY AN HCP OR REQUIRES EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT PERMANENT ORGAN DAMAGE (ELEVATED BLOOD GLUCOSE LEVEL AND SYMPTOMS E.G., MODERATE TO LARGE KETONES, NAUSEA, VOMITING, ABDOMINAL PAIN, CONFUSION) AND LOT 6007190 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET TUBING WAS NOT INSERTED PROPERLY AND PATIENT FACED A HIGH BLOOD GLUCOSE LEVEL OF 546 MG/DL WHICH WAS TREATED BY CORRECTION BOLUS VIA PUMP. THERFORE, ON (B)(6) 2024, THE PATIENT FIRST WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL. FURTHER, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT. DURING HOSPITALISATION, THE PATIENT RECEIVED FLUIDS OF SALINE (UNKNOWN), INSULIN, AND UNSPECIFIED MEDICATION (DRUG NAME UNKNOWN) INTRAVENOUSLY AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. MOREOVER, THE INFUSION SET WAS USED FOR THREE DAYS. ON (B)(6) 2024, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. NO FURTHER INFORMATION AVAILABLE 22-APR-2024,

    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
    2320044 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002835 6001679 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R