BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-A (ABO1)

    MDR report key: 1983142 · Received January 17, 2011

    Report

    Report Number
    9610824-2011-00002
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    November 22, 2010
    Report Date
    January 14, 2011
    Manufacturer
    BIO-RAD MED DIAGNOSTICS GMBH
    Product Code
    KSF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF AN EXTERNAL CONTROL WITH SERACLONE ANTI-A ART # 801325100, LOT 7018010-04. THE CUSTOMER HAS SENT US THE EXTERNAL CONTROL CALLED CONTROCELL 4 BUT NOT THE COMPLAINED LOT OF SERACLONE ANTI-A. THE CONTROCELL 4 WAS HEMOLYTIC AND ALREADY EXPIRED WHEN WE RECEIVED IT. THE EXPIRY DATE OF THE CONTROL WAS 2010-12-13. INSPITE OF THIS, THE CONTROCELL 4 WAS TESTED ON THE RETENTION SAMPLE OF SERACLONE ANTI-A. THE CONTROCELL 4 SHOWED A NEGATIVE REACTION. BUT DUE TO VERY STRONG STICKY EFFECTS, THE RESULTS HAD TO BE SHAKEN VERY STRONGLY. ACCORDING TO THE RESULT SHEET OF CONTROCELL 4 THE AFFECTED CONTROL CELL IS A WEAK REACTING CONTROL. THE AFFECTED LOT SERACLONE ANTI-A WAS ALSO TESTED ADDITIONALLY WITH DIFFERENT CALLS: ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD GROUPING REAGENT ANTI-A (ABO1) SERACLONE ANTI-A KSF BIO-RAD MED DIAGNOSTICS GMBH 7018010-04

    Patients

    Seq Age Sex Outcome Treatment
    1 IMMUCOR ANTI-A, LOT# 104008 EXP. 8/25/2010| BROMELIN (B)(4) LOT# 7024151 EXP. 12/15/2010| ALBA QOUTIENT ANTI-A, LOT# V089854 EXP. 8/28/2011