BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19266098 · Received May 8, 2024

    Report

    Report Number
    3003442380-2024-00410
    Event Type
    Injury
    Date Received
    May 8, 2024
    Report Date
    January 23, 2026
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE. 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 WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6001778 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 17-FEB-2024, IT WAS REPORTED THAT THE PATIENT DID NOT KNOW WHAT SHE WAS DOING AS HER BLOOD GLUCOSE LEVEL WENT LOW. THEREFORE, ON (B)(6) 2024, AT 03:00 PM, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF 39 MG/DL. FURTHER, THE PATIENT STAYED FOR THREE DAYS IN THE HOSPITAL. 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
    771046 QUICK SET PARADIGM UNO QUICK-SET 60/6 SC1 MECA FPA 6001778 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown