BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN

    MDR report key: 11931020 · Received June 3, 2021

    Report

    Report Number
    2250051-2021-00032
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 3, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO PERFORM RETAIN TESTING SINCE THIS EVENT WAS REPORTED ON 14MAY2021 AND PRODUCT EXPIRED ON 04MAY2021. ORTHO PERFORMED BATCH REVIEW, COMPLAINT REVIEW BY LOT AND DONOR HISTORY 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 · 0

    CUSTOMER CONTACTED TSC TO REPORT FALSE NEGATIVE RESULTS OF SCREENING CELL 1 FOR ONE PATIENT USING 0.8% SURGISCREEN LOT VSS269 EXP 04-MAY-2021 WITH MTS ANTI-IGG LOT 113020001-02 EXP 1-OCT-2021. RELEVANT INFORMATION: ISSUE STARTED ON: ORIGINAL TESTING (B)(6) 2021, DISCREPANCY IDENTIFIED (B)(6) 2021, REPORTED 14-MAY-2021. MICROTUBES/WELLS OR CELL AFFECTED: SC1. REACTION GRADE OBTAINED: NEGATIVE. CUSTOMER WAS EXPECTING: POSITIVE. INCUBATION TIME (FOR MANUAL TEST ONLY): NA. TEST REPEATED: REPEATED WITH ALTERNATE LOT. METHOD/RESULT OBTAINED BY REPEATING: POSITIVE. SAMPLE ID: ORIGINAL (B)(6). NUMBER OF SAMPLES AFFECTED? ONE. WAS QC AFFECTED? NO. WAS ANY EXPIRED PRODUCT USED? NO. WHEN WAS THE LAST SUCCESSFUL QC RUN? (B)(6) 2021. PATIENT CLINICAL HISTORY: PATIENT HAS NOT BEEN TRANSFUSED. 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: ORIGINAL SAMPLE RETESTED WITH NEW LOT. ACTIONS ALREADY PERFORMED BY CUSTOMER: ALL TESTING UTILIZED MTS ANTI-IGG CARD LOT 113020001-02. INITIAL SAMPLE ((B)(6)) TESTED 21-APR-2021. ANTIBODY SCREEN WITH VSS269 WAS NEGATIVE. SECONDARY SAMPLE ((B)(6)) TESTED (B)(6) 2021. ANTIBODY SCREEN WITH VSS277 WAS POSITIVE SC1. ANTIBODY ID PERFORMED WITH VRA378 IDENTIFIED BIG C POSITIVE. INITIAL SAMPLE RETESTED (B)(6) 2021. ANTIBODY SCREEN WITH VSS277 WAS POSITIVE SC1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824798 ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VSS269

    Patients

    Seq Age Sex Outcome Treatment
    1