BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-JKB

    MDR report key: 2346747 · Received November 23, 2011

    Report

    Report Number
    9610824-2011-00168
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    October 11, 2011
    Report Date
    February 3, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    PRIMARILY THE CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS OF TWO DIFFERENT SAMPLES WITH SERACLONE ANTI-JK(B). THE CUSTOMER INFORMED US THAT THEY INITIATED AN INTERNAL INVESTIGATION AND DISCOVERED THAT THE FALSE POSITIVE REACTION OF ONE OF THE AFFECTED SAMPLES WAS CAUSED BY A TECHNICIAN ERROR. THE SECOND PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE RESULT WAS SENT TO US FOR QUALITY CONTROL, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. THE SAMPLE WAS RE-TESTED IN OUR QUALITY CONTROL LABORATORY WITH OUR RETAINED SAMPLE OF SERACLONE ANTI-JK(B). THE SAMPLE CORRECTLY REACTED NEGATIVELY. THE RESULT OF OUR SEROLOGICAL TESTING WAS CONFIRMED BY THE MOLECULAR TYPING IN AN EXTERNAL LABORATORY. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE WITH DIFFERENT JK(A+B+) RED CELLS. ALL POSITIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JK(B) FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS OF TWO DIFFERENT SAMPLES WITH SERACLONE ANTI-JK(B). THE CUSTOMER STATED THAT THE PATIENT SAMPLES ARE GOING TO BE FORWARDED TO US BUT NOT THE ALLEGEDLY DEFECTIVE PRODUCT. WE ARE STILL WAITING FOR THESE SAMPLES. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF SERACLONE ANTI-JKB WITH DIFFERENT JK(A+B+) RED CELLS. ALL POSITIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING BY THE QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JK(B) FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD GROUPING REAGENT ANTI-JKB SERACLONE ANTI-JKB KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7045110-01

    Patients

    Seq Age Sex Outcome Treatment
    1