BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II

    MDR report key: 2523088 · Received June 29, 2010

    Report

    Report Number
    9610824-2010-00002
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Date of Event
    April 15, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    DEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL WAS BASED ON SERVICE REPORTS. BIO-RAD LABORATORIES INC ACQUIRED THE BIOTEST MEDICAL DIAGNOSTICS (B)(4) ON JANUARY 6, 2010. THE COMPANY NAME WAS CHANGED TO BIO-RAD MEDICAL DIAGNOSTICS ON MARCH 23, 2010. THE STN# 125098.

    Description of Event or Problem · 1

    THE TANGO INSTRUMENT (SERIAL NO. (B)(4)) INTERPRETED A VISUALLY WEAK POSITIVE REACTION AS NEGATIVE. THE IMAGE APPEARS HAZY AND OFF-CENTERED. SAMPLE IDENTIFIED AS HAVING AN ANTI-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II ANTI-HUMAN GLOBULIN DEW BIO-RAD MEDICAL DIAGNOSTICS GMBH 7915150-04

    Patients

    Seq Age Sex Outcome Treatment
    1