BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

    MDR report key: 10125291 · Received June 5, 2020

    Report

    Report Number
    2250051-2020-00023
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 5, 2020
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY, AND DONOR COMPLAINT REVIEW. 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

    EVENT 1 OF 2 (VISION). CUSTOMER CONTACTED TSC TO REPORT A FALSE NEGATIVE REACTION ON VISION ANALYZER OF SELECTOGEN LOT VS275 IN MTS ANTI-IGG CARD WITH PATIENT POSITIVE FOR ANTI-FYA AND ANTI-BIG C. ISSUE STARTED ON: (B)(6) 2020, REPORTED 19-MAY-2020. MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: SELECTOGEN CELL 1 AND 2. REACTION GRADE OBTAINED: NEGATIVE. CUSTOMER WAS EXPECTING: POSITIVE FOR FYA AND BIG C (BOTH CELLS POSITIVE). TEST REPEATED: YES, MANUALLY. METHOD/RESULT OBTAINED BY REPEATING: NEGATIVE. SAMPLE ID: NOT PROVIDED. NUMBER OF SAMPLES AFFECTED? ONE PATIENT. WAS QC AFFECTED? NO. WAS ANY EXPIRED PRODUCT USED? NO. WHEN WAS THE LAST SUCCESSFUL QC RUN? (B)(6) 2020. TRANSFUSION HISTORY: TRANSFUSED FYA AND BIG C NEGATIVE UNIT ON (B)(6) 2020. DONOR INFORMATION (RELEVANT IF ISSUE OCCURRED POST-TRANSFUSION): NOT PROVIDED. UNIT FYA AND BIG C NEGATIVE. NUMBER OF BLOOD UNIT TRANSFUSED: ONE. PRODUCT HANDLING PROTOCOL: CASSETTE/GEL CARD STORAGE TEMPERATURE RANGE: AS PER IFU. CASSETTE/GEL CARD ORIENTATION: UPRIGHT. RBC STORAGE AND HANDLING: AS PER IFU. VISUAL APPEARANCE BEFORE USE: ACCEPTABLE. WAS THE VIAL FRESHLY OPENED? NO. OTHER RELEVANT INFORMATION: 0.8% SELECTOGEN QCD DAILY PRIOR TO USE. ACTIONS ALREADY PERFORMED BY CUSTOMER: CUSTOMER HAD A PRE-TRANSFUSION SAMPLE FROM (B)(6) 2020, THAT WAS SENT TO REFERENCE LAB FOR FURTHER WORKUP (CUSTOMER SUSPECTED OTHER LOW INCIDENCE ANTIBODIES AS WELL AS PANEL WAS NOT CLEAR). PANEL LOTS UTILIZED RESOLVE PANEL A AND RESOLVE PANEL B CURRENT SAMPLE WAS NOT TESTED AGAINST PANELS. OLDER PRETRANSFUSION SAMPLE WAS ALSO REPEATED AGAINST 0.8% SELECTOGEN LOT VS275 AND BOTH CELL 1 AND 2 WERE WEAKLY POSITIVE. CUSTOMER UNABLE TO ANTIGEN TYPE REAGENTS OR SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588464 ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VS275

    Patients

    Seq Age Sex Outcome Treatment
    1