BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3 ML K2E K2EDTA 13X75 LAVENDER

    MDR report key: 17181147 · Received June 22, 2023

    Report

    Report Number
    1125230-2023-00029
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4): NO SAMPLES WERE RECEIVED FOR EVALUATION. NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. NO DATA WERE PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE CAUSE OF THE EVENT CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION.

    Description of Event or Problem · 0

    CUSTOMER STATES THEY ARE SEEING A STABILITY ISSUE WITH THE MCV [MEAN CORPUSCULAR VOLUME] AND RDW [RED BLOOD CELL DISTRIBUTION WIDTH] NOT BEING STABLE PAST 16 HOURS. CUSTOMER SEES HIGH MCV'S FROM OUTPATIENTS EVEN THOUGH THE SPECIMENS ARE REFRIGERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68985 VACUETTE® TUBE 3 ML K2E K2EDTA 13X75 LAVENDER EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 454246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown