BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENTS ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE

    MDR report key: 7730149 · Received July 29, 2018

    Report

    Report Number
    2250051-2018-00069
    Event Type
    Malfunction
    Date Received
    July 29, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 29, 2018
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE REPORTED CUSTOMER ISSUE WAS UNABLE TO BE CONFIRMED. CUSTOMER SAMPLE WAS NOT RETURNED FOR INVESTIGATION. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT TWO DONORS WERE EXHIBITING B(A) PHENOMENON WITH ANTI-A BIOCLONE. THE FIRST DONOR WAS TESTED USING LOT BAA614A (MXP 2033497). THE SECOND DONOR WAS TESTED USING LOT BAA615A (MXP 2033503). BOTH DONORS TESTED 1+ WITH ANTI-A BIOCLONE. TESTING WITH PRODUCT FROM TWO OTHER MANUFACTURERS DID NOT SHOW ANY REACTIVITY WITH ANTI-A. ISSUE STARTED ON:(B)(6) 2018 FOR THE FIRST DONOR. ON (B)(6) 2018 FOR THE SECOND DONOR. REPORTED (B)(6) 2018. METHODOLOGY USED: TUBE. REACTION GRADE OBTAINED: 1+, CUSTOMER WAS EXPECTING: NEGATIVE. DAILY QC PERFORMED AND FOUND TO BE ACCEPTABLE. REAGENT HAD A NORMAL APPEARANCE PRIOR TO USE. DONOR HAS BEEN DEFERRED FROM RED CELL DONATIONS IN THE FUTURE. THEY WILL BE ALLOWED TO DONATE PLASMA AND PLATELETS. ACCOUNT DID STATE THAT THIS IS REPORTABLE FOR THEM TO THE FDA. THE IFU STATES: THE ANTI-A (ANTI-ABO1) REAGENT MAY ALSO DETECT PREVIOUSLY UNRECOGNIZED A (ABO1) ANTIGEN IN A SMALL NUMBER OF GROUP B INDIVIDUALS NOW IDENTIFIED AS B(A) CELLS. REPORTED STUDIES INDICATE THAT INCIDENCE OF THIS OCCURRENCE IS APPROXIMATELY 0.1% OF GROUP B CELLS TESTED. THE AGGLUTINATION IS USUALLY WEAKER THAN EXPECTED, MIXED-FIELD AND IS EASILY DISPERSED. IN CASES WHERE THE RESULTS WITH THIS ANTI-A (ANTI-ABO1) REAGENT ARE QUESTIONABLE, FURTHER TESTING OF THE RED BLOOD CELLS WITH HUMAN POLYCLONAL ANTI-A OR MONOCLONAL ANTI-A DERIVED FROM A HYBRIDOMA CELL LINE OTHER THAN MH04 THAT IS KNOWN TO BE NONREACTIVE WITH B(A) RED BLOOD CELLS MAY BE USEFUL IN DISCREPANCY RESOLUTION. ACCOUNT DID STATE THAT THEY ARE CHANGING THE DONOR TYPE TO AB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572057 BLOOD GROUPING REAGENTS ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE ANTISERA KSZ ORTHO CLINICAL DIAGNOSTICS BAA615A

    Patients

    Seq Age Sex Outcome Treatment
    1