BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL C

    MDR report key: 11967535 · Received June 9, 2021

    Report

    Report Number
    2250051-2021-00036
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 9, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ORTHO PERFORMED BATCH RECORD REVIEW, COMPLAINT REVIEW, DONOR HISTORY, COMPLAINT REVIEW BASED ON DONOR HISTORY. UNABLE TO PERFORM RETAIN TESTING SINCE EVENT WAS REPORTED ON 20MAY2021 AND PRODUCT EXPIRED ON 18MAY2021. 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 REPORTING ONE EVENT OF FALSE NEGATIVE REACTION WHEN TESTING A SAMPLE FOR ANTI- E USING THE "FICIN TREATED CELLS" FOR 0.8% RESOLVE PANEL C LOT # VRC283 EXPIRED MAY-18-21. CUSTOMER WAS EXPECTING TO SEE POSITIVE REACTIONS WITH THE E-POSITIVE CELLS ON THE TREATED PORTION OF THE PANEL C, IN CONFIRMING THE ANTI-E. RELEVANT INFORMATION: - ISSUE STARTED ON: OCCURRED ON (B)(6) 2021: REPORTED 05-20-21 - MICROTUBES/WELLS OR CELL: ALL E-POSITIVE DONOR CELLS - REACTION GRADE OBTAINED: NEGATIVE - CUSTOMER WAS EXPECTING: POSITIVE REACTION - INCUBATION TIME (FOR MANUAL TEST ONLY):N/A - TEST REPEATED:YES; USING A DIFFERENT LOT# - SAMPLE ID: NO REPORTED - NUMBER OF SAMPLES AFFECTED? ONE - WAS QC AFFECTED?NO - WAS ANY EXPIRED PRODUCT USED?NO - WHEN WAS THE LAST SUCCESSFUL QC RUN? RUN ON DAY OF USE PATIENT CLINICAL HISTORY: - PATIENT'S DIAGNOSIS:N/A - DONOR INFORMATION (RELEVANT IF ISSUE OCCURRED POST-TRANSFUSION):N/A - NUMBER OF BLOOD UNIT TRANSFUSED: N/A BLOOD GROUP PHENOTYPE RESULT:N/A: SAMPLE WITH NO HISTORY HAS A POSITIVE ABS SCREEN AND ANTI-E WAS ID USING THE NON-TREATED POSTION OF 0.8% RESOLVE PANEL C LOT # VRC283: BUT IN AN ATTEMPT TO REPEAT THE TESTING WITH THE FICIN-TREATED PORTION OF THE PANEL, CLAIMED ALL REACTIONS WERE NEGATIVE PRODUCT HANDLING PROTOCOL: - CASSETTE/GEL CARD STORAGE TEMPERATURE RANGE: AS PER IFU'S - CASSETTE/GEL CARD ORIENTATION:AS PER IFU'S - RBC STORAGE AND HANDLING:AS PER IFU'S - VISUAL APPEARANCE BEFORE USE:AS PER IFU'S - WAS THE VIAL FRESHLY OPENED?AS PER IFU"S - OTHER RELEVANT INFORMATION:N/A ACTIONS ALREADY PERFORMED BY CUSTOMER: SEE ABOVE. TROUBLESHOOTING: TSC RECOMMEND CUSTOMER REPEAT TESTING USING CURRENT LOT # OF 0.8% RESOLVE PANEL C LOT # VRC284; TESTING WAS PERFORMED USING MTS IGG GEL CARD. ( LOT # NOT PROVIDED). REVIEW TECHNIQUE WITH CUSTOMER NEXT ACTION: WILL FOLLOW UP WITH SITE TSC FOLLOWED UP WITH SITE AND WAS TOLD WHEN TESTING WAS REPEATED USING 0.8% RESOLVE PANEL C LOT # VRC284- TREATED CELLS, THE ANTI-E WAS IDENTIFIED. CUSTOMER IS ONLY REPORTING INCIDENT FOR DOCUMENTATION. DISCUSSED WITH CUSTOMER THAT PANEL C LOT # VRC 283 -EXPIRED ON 5-18-21. RECOMMEND CUSTOMER REPORTED ALL FALSE NEGATIVE REACTIONS AS THEY OCCURRED FOR INVESTIGATION TO BE PERFORMED. SATISFIED WITH DOCUMENTATION. NO FURTHER ACTION REQUIRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865872 ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL C REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VRC283

    Patients

    Seq Age Sex Outcome Treatment
    1