BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II

    MDR report key: 2554395 · Received May 7, 2010

    Report

    Report Number
    9610824-2010-00008
    Event Type
    Other
    Date Received
    May 7, 2010
    Date of Event
    April 1, 2010
    Report Date
    May 5, 2010
    Manufacturer
    BIO-RAD MED DIAGNOSTICS GMBH
    Product Code
    DEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIO-RAD LABS INC ACQUIRED THE BIOTEST (B)(4) ON 1/6/2010. THE COMPANY NAME WAS CHANGED TO BIO-RAD (B)(4) ON (B)(4) 2010.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ANTIBODY S FROM A SAMPLE DRAWN (B)(6) 2010, THAT WAS INTERPRETED BY THE TANGO AS NEGATIVE, HOWEVER THE VISUAL RESULT APPEARED TO BE A WEAK POSITIVE. SO THE SAMPLE WAS TESTED IN GEL INDICATING AN ANTI-S. THE CUSTOMER REPORTED THE LOT NUMBERS OF THE USED TANGO REAGENTS AND SENT US THE PT SAMPLE. THE PT SAMPLE CONTAINED VERY LITTLE PLASMA (LESS THAN 100 UL). DUE TO THIS VERY SMALL AMOUNT OF MATERIAL IT WAS NOT POSSIBLE TO TEST THE SAMPLE ON THE TANGO. THE SAMPLE WAS TESTED WITH THE CELL 1 OF BIOTESTCELL 1 AND 2 (S+S+, HETEROZYGOUS FOR S ANTIGEN) IN THE TUBE TECHNIQUE AND REACTED POSITIVE. THE AFFECT LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II (RETENTION SAMPLE OF QC LAB) WAS CHECKED AND REACTED CORRECTLY POSITIVE. FURTHERMORE THE AFFECTED LOT OF BIOTESTCELL 1 AND 2 (RETENTION SAMPLE OF QC LAB) WAS TESTED, BOTH CELLS WHICH ARE BOTH HETEROZYGOUS FOR THE S ANTIGEN SHOWED A "NORMAL" EXPRESSION OF THE S ANTIGENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II AHG SOLIDSCREEN II DEW BIO-RAD MED DIAGNOSTICS GMBH 7915150-03

    Patients

    Seq Age Sex Outcome Treatment
    1