BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 5970535 · Received September 22, 2016

    Report

    Report Number
    3005290010-2016-00089
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    August 23, 2016
    Report Date
    September 21, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016 A CLINIMACS CD34 SELECTION WAS PERFORMED BY THE CUSTOMER. IN TOTAL 9.5XL0E9 WBC (WHITE BLOOD CELLS) CONTAINING 7.2XL0E7 CD34+ CELLS WERE PROCESSED USING ONE VIAL OF CLINIMACS CD34 REAGENT AND THE ENRICHMENT PROGRAM CD34 SELECTION 1 APPLYING THE CLINIMACS TUBING SET. THE CD34+ YIELD AS WELL AS THE PURITY OF THE TARGET CELLS IN THE TARGET CELL FRACTION AFTER THE SELECTION HAVE BEEN REPORTED TO BE VERY LOW (YIELD: 4.4%; PURITY: 14.6%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621419 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT OVG MILTENYI BIOTEC GMBH N/A 6160506001

    Patients

    Seq Age Sex Outcome Treatment
    1