BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN SOLIDSCREENII - DONOR

    MDR report key: 2101874 · Received April 19, 2011

    Report

    Report Number
    9610824-2011-00050
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    DEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: THE TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF ANTI-HUMAN GLOBULIN SOLIDSCREEN II-DONOR. ACCORDING TO THE INSTRUCTION FOR USE, A HANDLING'S FAILURE OF CUSTOMER CANNOT BE EXCLUDED. THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT. WE HAD FURTHER COMPLAINTS RELATED TO THIS LOT. STN# 125098.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED FALSE NEGATIVE REACTIONS OF A CONTROL WITH ANTI-HUMAN GLOBULIN SOLIDSCREEN II-DONOR AFTER USING THE SAME BOTTLE FOR ABOUT THREE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN SOLIDSCREENII - DONOR ANTI-HUMAN GLOBULIN SOLIDSCREENII - DONOR DEW BIO-RAD MEDICAL DIAGNOSTICS GMBH 1023070

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO OPTIMO, (B)(4)