BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 5904665 · Received August 25, 2016

    Report

    Report Number
    3005290010-2016-00085
    Event Type
    Malfunction
    Date Received
    August 25, 2016
    Date of Event
    July 5, 2016
    Report Date
    August 22, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CLINIMACS CD34 SELECTION HAS BEEN PERFORMED BY THE CUSTOMER. THE CUSTOMER COMPLAINED THAT THE ENRICHED CD34+ STEM CELLS WERE ANTIGEN POSITIVE FOR CD56 AFTER THE CELL ENRICHMENT. THE PATIENT RECEIVED THE CELLULAR TRANSPLANT. THEREFORE ANY RISK FOR THE PATIENT COULD BE RULED OUT. THE FORTHCOMING CYTOPENIA WAS NOT DUE TO ANY OF THE COMPONENTS OF THE CLINIMACS CD34 SYSTEM AS STATED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556042 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT OVG MILTENYI BIOTEC GMBH NOT KNOWN 6160602011

    Patients

    Seq Age Sex Outcome Treatment
    1