BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19346997 · Received May 17, 2024

    Report

    Report Number
    3003442380-2024-02059
    Event Type
    Injury
    Date Received
    May 17, 2024
    Report Date
    April 25, 2025
    Product Code
    FPA
    UDI-DI
    05705244017429
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-02059. 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 6003556 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 6003556 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 MANUFACTURED IN THE LINE MULTIVAC 12, ON 11/OCT/2023, 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 25/APR/2025 AGAINST MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, 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 6003556 AND ANOTHER 1 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, ONLY ONE 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 CORRECTIVE AND PREVENTIVE ACTION (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 CANADA IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE (BG) LEVELS AND WAS HOSPITALIZED FOR A WEEK. THEIR BG LEVEL AT THE TIME OF ADMISSION WAS OVER 21 MMOL/L. THE HOSPITALIZATION WAS DUE TO HIGH BG AND DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS TAKEN TO THE HOSPITAL BY AMBULANCE AND REPORTED SYMPTOMS OF FEELING VERY SICK AND VOMITING BLOOD. THEY TESTED POSITIVE FOR KETONES, CONFIRMING THE PRESENCE OF DKA. THE PATIENT RECEIVED TREATMENT WITH AN INTRAVENOUS (IV) INSULIN DRIP DURING THEIR HOSPITAL STAY. 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
    401563 QUICK SET PARADIGM UNO QUICK-SET 60/6 SC1 MCAN FPA 6003556 05705244017429

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization