BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION TUBES EDTA

    MDR report key: 11957031 · Received June 8, 2021

    Report

    Report Number
    1125230-2021-00053
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Report Date
    June 8, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. NO SAMPLES WERE RECEIVED FOR EVALUATION. NO CUSTOMER PICTURES WERE RECEIVED. NO MATERIAL NUMBER WAS PROVIDED BY THE CUSTOMER. NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. NO FURTHER INFORMATION OR CLARIFICATION WAS RECEIVED FROM THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE COMPLAINT IS CLOSED AS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES TUBES ARE FILLING BEYOND THE FILL LINE. THIS IS CAUSING AN ERROR WITH THEIR ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859893 VACUETTE BLOOD COLLECTION TUBES EDTA EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1