BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

    MDR report key: 10631711 · Received October 5, 2020

    Report

    Report Number
    2250051-2020-00052
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 5, 2020
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY, AND DONOR COMPLAINT REVIEW. RETAIN TESTING UNABLE TO BE PERFORMED SINCE CUSTOMER REPORTED EVENT ON (B)(6) 2020 AND PRODUCT EXPIRED ON 08SEP2020. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE REPORTED CUSTOMER ISSUE WAS UNABLE TO BE CONFIRMED. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    TESTING PERFORMED ON VISION J#: (B)(4). CUSTOMER CONTACTED TSC TO REPORT IND RESULT ON CELL# 2 TESTED ON (B)(6) WITH 0.8% SELECTOGEN LOT# VS294 EXP 9.8.2020 ON MTS IGG GEL CARD LOT#041420001-01. CUSTOMER REPORTS UPON REVIEW OF IND RESULT CUSTOMER MODIFIED RESULT TO NEG. CUSTOMER REPORTS QC NOT AFFECTED. CUSTOMER TESTED SAME PATIENT DIFFERENT SAMPLE ON (B)(6) AND VISION GRADED RESULT 1+ POS ON CELL# 2 WITH 0.8% SELECTOGEN LOT# VS300 EXP: 041420001-14. CUSTOMER PERFORMED 0.8% PANEL C FICIN (LOT NUMBER REQUESTED NOT PROVIDED) AND CUSTOMER WAS ABLE TO IDENTIFY ANTI-E. CUSTOMER REPORTS PATIENT DID NOT HAVE PAST MEDICAL HX OF ANTI-E. CUSTOMER REPORTS PATIENT DID RECEIVE 2 UNITS OF RED CELLS BETWEEN SPECIMENS BUT WERE E AG NEG. NO HARM CAME TO PATIENT DUE TO THIS EVENT. RELEVANT INFORMATION: ISSUE STARTED ON: (B)(6) 2020. MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: CELL# 2. REACTION GRADE OBTAINED: IND ? CUSTOMER WAS EXPECTING: POS. INCUBATION TIME (FOR MANUAL TEST ONLY):VISION. TEST REPEATED: YES METHOD/RESULT OBTAINED BY REPEATING: IND ? SAMPLE ID: (B)(6). NUMBER OF SAMPLES AFFECTED? 2. WAS QC AFFECTED? NO. WAS ANY EXPIRED PRODUCT USED? NO. WHEN WAS THE LAST SUCCESSFUL QC RUN? TODAY. TRANSFUSION HISTORY: 2 UNITS OF RED CELLS E AG NEG. ONE UNIT RECEIVED ON (B)(6) AND ONE ON (B)(6). PRODUCT HANDLING PROTOCOL: CASSETTE/GEL CARD STORAGE TEMPERATURE RANGE:ACCORDING TO IFU. CASSETTE/GEL CARD ORIENTATION: ACCORDING TO IFU. RBC STORAGE AND HANDLING:ACCORDING TO IFU. VISUAL APPEARANCE BEFORE USE: ACCEPTABLE. WAS THE VIAL FRESHLY OPENED? NO. CUSTOMER MODIFIED INITIAL RESULT TO NEG AFTER USER REVIEW. TSC CLASSIFYING THIS CALL BASED ON CUSTOMERS CLAIM OF READING THE CARD AS NEG. TSC DISCUSSED WITH CUSTOMER THE DIFFERENT AG EXPRESSION ON DIFFERENT LOTS OF DONORS , CUSTOMER CONTENT WITH DISCUSSION. TSC REFERRED CUSTOMER TO IFU OF 0.8% SELECTOGEN. "FOR ANTIBODY DETECTION AND IDENTIFICATION, DIFFERENT SEROLOGICAL METHODS ARE OPTIMAL FOR DIFFERENT ANTIBODIES. NO SINGLE ANTIBODY SCREENING OR IDENTIFICATION METHOD OPTIMALLY DETECTS ALL ANTIBODIES. IN SOME LOW IONIC STRENGTH TEST SYSTEMS, CERTAIN ANTI-E AND ANTI-K ANTIBODIES HAVE BEEN REPORTED TO BE NONREACTIVE." CUSTOMER REQUESTING EMAIL OF IFU. CUSTOMER NOT REQUESTING FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089599 ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VS294

    Patients

    Seq Age Sex Outcome Treatment
    1