BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIISED

    MDR report key: 20640868 · Received November 8, 2024

    Report

    Report Number
    20640868
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    June 16, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ALCOR SCIENTIFIC LLC.
    Product Code
    GKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MINIISED ESR ANALYZER NOT FUNCTIONING. ATTEMPTED TO TURN IT ON, UNPLUG AND PLUG BACK IN. DOES NOT POWER ON ¿ SHOULD BE ON ALL THE TIME. QC RAN. SENT LABS TO ANOTHER LAB FOR COMPLETION. MANUFACTURER RESPONSE FOR ISED ANALYZER, MINISED (PER SITE REPORTER). UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044390 MINIISED DEVICE, AUTOMATED SEDIMENTATION RATE GKB ALCOR SCIENTIFIC LLC. 112-01017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose