BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    MDR report key: 6086854 · Received November 8, 2016

    Report

    Report Number
    2250051-2016-00092
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY, AND DONOR COMPLAINT REVIEW. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER CONTACTING ORTHO TO REPORT FALSE NEGATIVE REACTIONS WITH A PATIENT LATER CONFIRMED TO HAVE AN ANTI-E TO THE CELL#3 AND 6 TO THE 0.8% RESOLVE PANEL A LOT# VRA259. CUSTOMER REPORTS INITIALLY TESTING THE SAMPLE AGAINST 0.8% SELECTOGEN LOT# VS962 AND REPORTS A 1+ REACTION WAS OBSERVED TO CELL#2 (E+) ON BOARD THE PROVUE. CUSTOMER REPORTS EVENT HAS ONLY OCCURED ON THIS SINGLE PATIENT, CUSTOMER REPORTS NO QC IS PERFORMED ON THIS 0.8% RESOLVE PANEL A IN QUESTION. CUSTOMER RESORTED TO TUBE METHODOLOGY WITH SELECTOGEN LOT# S936 WITH A POS MICROSCOPIC REACTION WITH SCREENING CELL#2. CUSTOMER REPORTS RESOLVE PANEL A LOT# RA041 EXP 10/25/2016 WAS MICROSCOPIC POS FOR ALL ANTI- E POS CELLS(#3 AND #6) . CUSTOMER PERFORMED PHENOTYPING FOR E ANTIGEN ON PATIENT WITH BIORAD PRODUCTS AND CUSTOMER REPORTS PATIENT IS NEGATIVE FOR E AG. CUSTOMER REPORTS AUTOCONTROL PERFORMED ON PATIENT IS NEGATIVE. ISSUE STARTED ON: (B)(6) 2016, FREQUENCY: 1X, E + DONORS NOT REACTING, MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: CELL#3 AND 6, METHODOLOGY USED: MANUAL GE,L INCUBATION TIME (FOR MANUAL TEST ONLY): 15MIN. REACTION GRADE OBTAINED: NEGATIVE, CUSTOMER WAS EXPECTING: POSITIVE, TEST REPEATED: YES, RESULT OBTAINED BY REPEATING: NEGATIVE, METHOD USED TO REPEAT: PROVUE. CUSTOMER REPORTS QC BEING ACCEPTABLE FOR THE LISTED PANEL A TRANSFUSION HISTORY: NO PREVIOUS HISTORY OF THE PATIENT AT THIS FACILITY. SAMPLE TYPE: EDTA. CARDS /CASSETTES/ STORAGE CONDITION TEMPERATURE: AS PER IFU. VISUAL APPEARANCE BEFORE USE: ACCEPTABLE, NO SIGNS OF HAZE OR HEMOLYSIS. REAGENT RED BLOOD CELL STORAGE AND HANDLING: AS PER IFU. STORED UNDERNEATH DIRECT LIGHT SOURCE: NO. ORTHO DISCUSSED POSSIBLE CAUSES OF THE FALSE NEGATIVE REACTION AND REFERRED THE CUSTOMER TO THE PACKAGE INSERT TO THE 0.8% RESOLVE PANEL A AND DISCUSSED DIFFERENCES IN ANTIBODY TITER AND PHENOTYPES OF THE REAGENT RED CELL DONORS MAY HAVE ATTRIBUTED TO THE FALSE NEGATIVE REACTION. ORTHO ALSO DISCUSSED HOW CELL CONCENTRATION CAN AFFECT RESULTS AND ADVISED THE CUSTOMER TO ALWAYS ENSURE THE 0.8% REAGENT RED CELLS ARE PROPERLY SUSPENDED PRIOR TO TESTING. CUSTOMER INDICATES THEIR UNDERSTANDING AND HAS INDICATED THAT THEIR CELLS ARE PROPERLY RE-SUSPENDED PRIOR TO USE. CUSTOMER REQUIRES NO ADDITIONAL FOLLOW UP AND IS SATISFIED WITH THE DOCUMENTATION OF THE REPORTED CONCERN. CUSTOMER HAS AGREED TO CONTACT ORTHO IF ANY ADDITIONAL QUESTIONS OR CONCERNS ARISE REGARDING THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735976 REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA259

    Patients

    Seq Age Sex Outcome Treatment
    1