BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN

    MDR report key: 11986181 · Received June 11, 2021

    Report

    Report Number
    2250051-2021-00038
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    June 8, 2021
    Report Date
    June 11, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ORTHO PERFORMED BATCH RECORD REVIEW, COMPLAINT REVIEW BY LOT AND DONOR HISTORY COMPLAINT REVIEW. UNABLE TO PERFORM RETAIN TESTING SINCE EVENT WAS REPORTED ON (B)(6) 2021 AND PRODUCT EXPIRED ON 04MAY2021. 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 2 FOR ONE PATIENT USING 0.8% SURGISCREEN LOT VSS269 EXP 04-MAY-2021 WITH MTS ANTI-IGG LOT 112020001-13. RELEVANT INFORMATION: - ISSUE STARTED ON: ORIGINAL TESTING (B)(6) 2021, DISCREPANCY IDENTIFIED (B)(6) 2021, REPORTED (B)(6) 2021 - MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: SC2 - REACTION GRADE OBTAINED: NEGATIVE (ALL 3 CELLS TESTED NEGATIVE). - CUSTOMER WAS EXPECTING: POSITIVE - INCUBATION TIME (FOR MANUAL TEST ONLY): NA - TEST REPEATED WITH ALTERNATE LOT ON BOTH VISIONS - METHOD/RESULT OBTAINED BY REPEATING: POSITIVE - SAMPLE ID: (B)(6) - NUMBER OF SAMPLES AFFECTED? ONE - WAS QC AFFECTED? NO - WAS ANY EXPIRED PRODUCT USED? NO - WHEN WAS THE LAST SUCCESSFUL QC RUN? 24-MAY-2021 ATIENT CLINICAL HISTORY: UNKNOWN BY REPORTER PRODUCT HANDLING: - 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: INITIAL PRE-TRANSFUSION SPECIMEN TESTED (B)(6) 2021 USING 0.8% SURGISCREEN LOT VSS269 EXP 04-MAY-2021 WITH MTS ANTI-IGG CARD LOT 112020001-13 ON VISION 50003187. ALL SCREENING CELLS RESULTED NEGATIVE. PATIENT TRANSFUSED 1 UNIT PACKED CELLS (B)(6) 2021 POST TRANSFUSION SPECIMEN TESTED (B)(6) 2021. SCREENING CELLS POSITIVE - PANEL TESTING IDENTIFIED ANTI-BIG E POSITIVE. (LOT INFORMATION NOT PROVIDED AT THIS TIME) REPEAT TESTING PERFORMED ON PRE-TRANSFUSION SPECIMEN AS PER SITE PROTOCOL (B)(6) 2021 USING 0.8% SURGISCREEN LOT VSS277 EXP 01-JUN-2021 WITH MTS ANTI-IGG CARD LOT 020921001-07. SCREENING CELL 2 RESULTED POSITIVE. PANEL TESTING PERFORMED ON PRE-TRANSFUSION SAMPLE USING 0.8% RESOLVE PANEL A LOT VRA380 EXP 15-JUN-2021 AND MTS ANTI-IGG CARD LOT 020921001-07. PATIENT SAMPLE IDENTIFIED AS ANTI-BIG E POSITIVE UNIT TYPING PERFORMED ON TRANSFUSED UNIT - UNIT BIG E POSITIVE. PATIENT HAS BEEN DISCHARGED FROM FACILITY AND IS BEING MONITORED. FURTHER INVESTIGATION AND TESTING ONGOING TO DETERMINE SEROLOGIC VERSUS HEMOLYTIC TRANSFUSION REACTION. TRANSFUSION REACTION REPORTED TO RISK MANAGEMENT TEAM AT FACILITY. CHU ASKED THE TSC TO FOLLOW-UP WITH THE CUSTOMER FOR FURTHER INFORMATION. CUSTOMER STATED THAT THE PATIENT HAD NO SYMPTOMS OF TRANSFUSION REACTION AT THE TIME OF TRANSFUSION ON (B)(6) 2021. PER THE CUSTOMER'S POLICY, WHEN A DISCREPANCY EXISTS BETWEEN PRE AND POST TRANSFUSION SAMPLES, THE PRE SAMPLE IS RETESTED. THE RETEST IDENTIFIED THE ANTIBODY, THEN THE BLOOD UNIT WAS TYPED AND FOUND TO HAVE THE CORRESPONDING ANTIGEN (THEREFORE, INCOMPATIBLE). THIS TRIGGERED THE CUSTOMER'S TRANSFUSION REACTION PROTOCOL AT THEIR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880515 ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VSS269

    Patients

    Seq Age Sex Outcome Treatment
    1