BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-JKA

    MDR report key: 2527106 · Received December 2, 2010

    Report

    Report Number
    9610824-2009-00011
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 27, 2009
    Report Date
    November 30, 2009
    Manufacturer
    BIOTEST MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT A PATIENT WAS TYPED NEGATIVE USING THE BLOOD GROUPING REAGENT ANTI-JK(A). THE CUSTOMER SENT US THE PATIENT SAMPLE AND THE COMPLAINED REAGENT. THE PATIENT SAMPLE WAS TESTED WITH THE COMPLAINED REAGENT IN THE QUALITY CONTROL LABORATORY ACCORDING TO THE INSTRUCTIONS FOR USE. THE TESTING WAS PERFORMED IN PARALLEL TO THE RETENTION SAMPLE. THE PATIENT REACTED NEGATIVE WITH BOTH REAGENTS, THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE. ADDITIONALLY TESTED JK(A) POSITIVE RED CELLS REACTED CORRECTLY POSITIVE WITH BOTH REAGENTS. FURTHER TESTS CONFIRMED THAT THE PATIENT IS JK(A) POSITIVE, BUT A TITRATION OF THE BLOOD GROUPING REAGENT WITH THE PATIENT SAMPLE AND JK(A) POSITIVE DONOR RED CELLS SHOWED THAT THE JK(A) ANTIGEN OF THE PATIENT IS WEAKENED. THE PATIENT COMPLAINT IS A SINGULAR CASE. WE HAVE NO HINTS THAT THE BLOOD GROUPING REAGENT MIGHT NOT BE ABLE TO DETECT THE JK(A) ANTIGEN. THE FINAL SEROLOGICAL TREATING OF THIS LOT MET ALL ACCEPTANCE CRITERIA. THE STABILITY DATA OF BLOOD GROUPING REAGENT ANTI-JK(A) IS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERACLONE ANTI-JKA SERACLONE KSZ BIOTEST MEDICAL DIAGNOSTICS GMBH 7838140-01

    Patients

    Seq Age Sex Outcome Treatment
    1