BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP MEGA SAMPLE PROCESSOR

    MDR report key: 507431 · Received January 21, 2004

    Report

    Report Number
    1058138-2004-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2004
    Date of Event
    December 18, 2003
    Report Date
    January 6, 2004
    Manufacturer
    TECAN AG
    Product Code
    JQW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS PREPARING ABO BLOOD GROUP FORWARDED TYPING AND ANTIBODY SCREENING TESTS ON THE TECAN MEGAFLEX-ID. THE CUSTOMER REPORTED INCONSISTENT RED CELL SUSPENSIONS, WHICH MAY BE INTERPRETED AS FALSE POSITIVE REACTIONS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP MEGA SAMPLE PROCESSOR PIPETTING AND DILUTING SYSTEM FOR CLINICAL USE JQW TECAN AG 700012 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA