BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 22103854 · Received May 29, 2025

    Report

    Report Number
    3003442380-2025-09757
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    April 18, 2025
    Report Date
    July 9, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244025288
    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 AND MANUFACTURING DATE UNDER H4. 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 NO MALFUNCTION BASED ON COMPLAINT INFORMATION. THE BATCH 6011328 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 6011328 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100, PACKAGED IN THE MACHINE M14, ON 02/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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 08/JUL/2025 AGAINST MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, HARM CODE MILD TO MODERATE DIABETIC KETOACIDOSIS WHICH THE PATIENT IS ABLE TO SELF MANAGE (ELEVATED BLOOD GLUCOSE LEVEL AND SYMPTOMS E.G., FREQUENT URINATION, INCREASED THIRST, INCREASED HUNGER, BLURRED VISION, FATIGUE, HEADACHES, ABDOMINAL PAIN, SMALL TO MODERATE KETONES, CONFUSION, PATIENT DESCRIBING FEELING SICK) AND LOT 6011328 AND NO OTHER COMPLAINT 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 RELATED TO COMPLAINT CODE, 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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN HYPERGLYCEMIC EVENT ON (B)(6) 2025. BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE EVENT. PATIENT WAS EXPERIENCED THE SYMPTOMS OF DIZZINESS, NAUSEA AND STOMACHACHE. 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
    994114 CONTACT DETACH UNO CONTACT DETACH G29 60/6 BETA FPA UNOMEDICAL A/S FG000016-03 6011328 05705244025288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown