BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-S (MNS3)

    MDR report key: 2320936 · Received November 3, 2011

    Report

    Report Number
    9610824-2011-00161
    Event Type
    Malfunction
    Date Received
    November 3, 2011
    Date of Event
    October 5, 2011
    Report Date
    November 20, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE DONOR SAMPLE WITH SERACLONE ANTI-S. THE CUSTOMER HAS SENT US THE AFFECTED DONOR SAMPLE BUT NOT THE ALLEGEDLY DEFECTIVE PRODUCT. THEREFORE THE DONOR SAMPLE WAS TESTED WITH THE RETAINED SAMPLE OF SERACLONE ANTI-S. THE SAMPLE REACTED NEGATIVELY. THE SAMPLE WAS ALSO TESTED WITH A COMPETITOR'S MONOCLONAL ANTI-S REAGENT AND ALSO REACTED NEGATIVELY. FURTHERMORE THE SAMPLE WAS TESTED WITH A POLYCLONAL REAGENT AND REACTED POSITIVELY. DUE TO THIS DISCREPANT TEST RESULT THE SAMPLE WAS SENT FOR MOLECULAR TYPING TO AN EXTERNAL LABORATORY. THE TESTING YIELDED IN THE RESULT: PRELIMINARY ASSUMED HYBRID GENE GYB-GYA/E(2)-GYB. THIS MENTIONED POLYMORPHISM IN EXON 3 OF THE GYP B GENE IS CHARACTERISTIC FOR A S/S FEATURE. DESPITE SEVERAL ATTEMPTS, AN AMPLIFICATION OF EXON 2 WAS NOT POSSIBLE. SINCE A MULTITUDE OF HYBRID GENES FOR GYPA, GYPB AND GYPE HAVE BEEN DESCRIBED IN THE LITERATURE, IT CAN BE ASSUMED THAT IN THIS CASE A MUTANT IS PRESENT. THE METHOD OF GENOMIC SEQUENCING DOES NOT IDENTIFY THESE HYBRID GENES, IN THIS CASE A RNA TEST WOULD BE APPROPRIATE. THE CUSTOMER WAS NOT ABLE TO SEND US A SAMPLE FOR RNA TESTING. THEREFORE THE CAUSE FOR THE NEGATIVE RESULT OF THE DONOR SAMPLE WITH SERACLONE ANTI-S COULD NOT BE RESOLVED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-S 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 REPORTED A FALSE NEGATIVE REACTION OF ONE DONOR SAMPLE WITH SERACLONE ANTI-S. THE CUSTOMER HAS SENT US THE AFFECTED DONOR SAMPLE BUT NOT THE ALLEGEDLY DEFECTIVE PRODUCT SAMPLE. THEREFORE THE DONOR SAMPLE WAS TESTED WITH THE RETAINED SAMPLE OF SERACLONE ANTI-S. THE SAMPLE REACTED NEGATIVELY. THE SAMPLE WAS ALSO TESTED WITH A COMPETITOR'S MONOCLONAL ANTI-S REAGENT AND ALSO REACTED NEGATIVELY. FURTHERMORE THE SAMPLE WAS TESTED WITH A POLYCLONAL REAGENT AND REACTED POSITIVELY. DUE TO THIS DISCREPANT TEST RESULT THE SAMPLE WAS SENT FOR MOLECULAR TYPING TO AN EXTERNAL LABORATORY. WE ARE STILL WAITING FOR THE RESULT. TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-S. 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-S (MNS3) SERACLONE ANTI-S (MNS3) KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7037080-01

    Patients

    Seq Age Sex Outcome Treatment
    1 ORTHO ANTI-S, LOT SS194B, EXP. 12/14/2012| IMMUCOR ANTI-S, LOT 622004, EXP. 09/03/2012| ORTHO ANTI-S, LOT SS194B, EXP. 12/14/2012| IMMUCOR ANTI-S, LOT 622004, EXP. 09/03/2012