BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-N (MNS2)

    MDR report key: 7372705 · Received March 27, 2018

    Report

    Report Number
    9610824-2018-00014
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 27, 2018
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WHEN TESTING BLOOD GROUPING REAGENT SERACLONE ANTI-N, THE NEGATIVE CONTROL YIELDED AN UNEXPECTED POSITIVE REACTION. THE CUSTOMER USED ORTHO GEL REAGENT RED CELLS FOR QC. THE CUSTOMER DID NOT PROVIDE THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED SIX DIFFERENT REAGENT RED BLOOD CELLS OF THE ANTIGEN CONSTELLATION MMSS WITH THEIR RETENTION SAMPLE OF SERACLONE ANTI-N. FIVE REAGENT RED BLOOD CELLS YIELDED CORRECTLY NEGATIVE RESULT, BUT ONE REAGENT RED BLOOD CELL SHOWED A WEAKLY (+/-) POSITIVE REACTION. ADDITIONALLY THE RETENTION SAMPLE OF SERACLONE ANTI-N WAS TESTED WITH ADDITIONAL FIVE DONOR SAMPLES (3 X MMSS, MMSS, MMSS). ALL REACTIONS WERE CORRECTLY NEGATIVE. FURTHERMORE PH VALUE WAS MEASURED AND POTENCY WAS TESTED. THE RETENTION SAMPLE MET ALL ACCEPTANCE CRITERIA. DUE TO THE SINGLE VERY WEAK (+/-) FALSE POSITIVE REACTION THE FINDINGS OF THE CUSTOMER WERE CONFIRMED BUT ONLY BY USING REAGENT RED BLOOD CELLS OF THE ANTIGEN CONSTELLATION MMSS. VERY WEAK NONSPECIFIC REACTIONS WITH SERACLONE ANTI-N WERE FOUND IN OUR QC TESTS ONLY IF THE RED CELLS HAD THE PHENOTYPE MMSS, MEANING N ANTIGEN NEGATIVE CELLS WITH DOUBLE-DOSE EXPRESSION (HOMOZYGOUS) OF THE S ANTIGEN. THE APPROXIMATE FREQUENCY OF THIS PHENOTYPE IS ONLY 6% IN CAUCASIANS. THE UNSPECIFIC REACTIONS WITH BLOOD GROUPING REAGENT ANTI-N WERE ONLY SPORADICALLY OBSERVED IN SAMPLES OF THIS PHENOTYPE. DUE TO THE FACT THAT THE ANTIBODY IS USUALLY NOT CLINICALLY RELEVANT, WILL NOT BE DETECTED WITH USUAL TEST METHODS INCLUDING 37°C INCUBATION AND THE LOW PHENOTYPE FREQUENCY, THE RISK OF A POSSIBLE DELAY (ANTIBODY IDENTIFICATION IN PATIENTS AND/OR ANTIGEN TESTING OF RED BLOOD CELL CONCENTRATES) IS NEGLIGIBLE. 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
    216041 BLOOD GROUPING REAGENT ANTI-N (MNS2) SERACLONE ANTI-N (MNS2) KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8629080-01 07611969952052

    Patients

    Seq Age Sex Outcome Treatment
    1