BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23081227 · Received September 18, 2025

    Report

    Report Number
    3003442380-2025-13814
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 10, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K991759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: CANADA. 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 COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011034, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 09-SEP-2025 AGAINST FINAL REPORTING DECISION EQUAL SERIOUS INJURY AND DEATH, LOT NUMBER CRITERIA EQUAL LOT NUMBER 6011034. THE COUNT OF COMPLAINT IS 4 WHICH IS EXCEEDS 3. FURTHER INVESTIGATION IS REQUIRED VIA CAPA DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINTS NUMBER ARE: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011034 WAS PACKAGED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 11-JAN-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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PHOTO WAS PROVIDED; PHYSICAL SAMPLES WILL NOT BE RETURNED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, THE THRESHOLDS OF 4 REPORTABLE COMPLAINTS ARE MET FOR THE LOT IN QUESTION AND MALFUNCTION CODE, FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED SEVERE DIABETIC KETOACIDOSIS (DKA) AND HIGH BLOOD GLUCOSE LEVELS REQUIRING HOSPITALIZATION. THE PATIENT REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THEY WERE ADMITTED TO HOSPITAL ON (B)(6) 2025, WHERE THEY RECEIVED MANUAL INSULIN INJECTIONS AND INTRAVENOUS (IV) DRIP TREATMENT. THE HOSPITALIZATION LASTED LESS THAN 24 HOURS. THE PATIENT, WHO HAS TYPE 1 DIABETES, HAD A BLOOD GLUCOSE READING OF 639 MG/DL UPON HOSPITAL ADMISSION. PRIOR TO HOSPITALIZATION, THE CUSTOMER REPORTED FEELING VERY TIRED, SICK/UNWELL, EXPERIENCING HEADACHES, AND GENERAL WEAKNESS. THE HOSPITAL CONFIRMED DKA AFTER TESTING FOR KETONES. WHILE AT THE HOSPITAL, THE PATIENT WAS TAKEN OFF THEIR INSULIN PUMP AND ADMINISTERED INSULIN VIA MANUAL INJECTIONS AND IV DRIP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705681 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6011034 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention