BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-E (RH5)

    MDR report key: 2104961 · Received May 20, 2011

    Report

    Report Number
    9610824-2011-00068
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WEAK FALSE POSITIVE REACTION OF A SAMPLE WITH SERACLONE ANTI-E ART. - NO. 802370100, LOT 7038140-01. WE ARE STILL WAITING FOR THE SAMPLE AND THE COMPLAINED PRODUCT WHICH WERE REQUESTED FROM THE CUSTOMER. THEREFORE OUR RETENSION SAMPLE WAS TESTED WITH DIFFERENT E-POSITIVE AND E-NEGATIVE RED CELLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DIDN'T OBSERVE ANY FALSE POSITIVE REACTIONS. CUSTOMER REPORTED THAT THE PT MOST LIKELY HAD A VARIANT ANTI-E. HE HAD SENT THE SAMPLE TO AN EXTERNAL REFERENCE LABORATORY FOR TESTING. HE IS STILL WAITING FOR THE COMPLETE RESULTS. TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE AFFECTED SERACLONE ANTI-E LOT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED PRODUCT. WE HAVE NO FURTHER COMPLAINTS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERACLONE ANTI-E (RH5) SERACLONE ANTI-E KSF BIO-RAD MEDICAL DIAGNOSTICS GMBH 7038140-01

    Patients

    Seq Age Sex Outcome Treatment
    1 ORTHO ANTI-E: LOT SEB372A, EXP. DATE: 06/25/2012| IMMUCOR ANTI-E: LOT 964020, EXP. DATE: 03/12/2012