BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICOLLECT® COMPLETE 0.25 / 0.5 ML K2E K2EDTA LAVENDER CAP

    MDR report key: 17181024 · Received June 22, 2023

    Report

    Report Number
    8020040-2023-00008
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    JKA
    PMA / PMN Number
    K182078
    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 WAS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061450 MINICOLLECT® COMPLETE 0.25 / 0.5 ML K2E K2EDTA LAVENDER CAP CAPILLARY BLOOD COLLECTION TUBE JKA GREINER BIO-ONE GMBH 450547

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown