BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2523087 · Received June 25, 2010

    Report

    Report Number
    9610824-2010-00003
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BIO-RAD MED DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2010 AN A NEG PT WAS DETERMINED AS O NEG. DISCREPANCY WAS DETECTED AS RESULT WAS TRANSFERRED TO HOST AND COMPARED WITH HISTORIC GROUP. REPEAT ON SAME SAMPLE ON SAME SYSTEM GAVE A NEG RESULT. THE WRONG RESULT WAS DETERMINED BY TANGO OPTIMO IN ABD CONFIRMATION ASSAY. THE CAUSE IS NOT KNOWN YET. THE CONCERNED SAMPLES WERE FLAGGED BY THE SYSTEM. THE TEMPERATURE IN THE LAB WAS HIGH, BUT NO OTHER SAMPLE SHOWED A WRONG RESULT. ALL REAGENTS USED WITH THE PT HAD BEEN TRANSFERRED TO AN OTHER SYSTEM AND PASSED QC WITHOUT ANY PROBLEM. THE REAGENTS HAD BEEN USED UP SO THEY COULDN'T BE SHIPPED FOR RETESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANGO OPTIMO AUTOMATED BLOOD GROUP ANALYZER KSZ BIO-RAD MED DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1