BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL B

    MDR report key: 9577376 · Received January 10, 2020

    Report

    Report Number
    2250051-2020-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 20, 2019
    Report Date
    August 11, 2020
    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

    UNDER SECTION D, "TYPE OF DEVICE CODE" WAS CHANGED FROM KSZ TO QHT TO PROPERLY REFLECT THE CORRECT PRODUCT CODE FOR REAGENT RED BLOOD CELLS.

    Description of Event or Problem · 0

    ON 05AUG2020, CHU IN RARITAN WAS MADE AWARE THAT ORTHO RECEIVED NOTIFICATION FROM THE FDA WITH A LETTER DATED 20APR2020. SEVERAL MDR REPORTS INVOLVING REAGENT RED BLOOD CELLS CONTAINED INCORRECT PRODUCT CODES. THE PROCODE KSZ WAS USED UNDER SECTION D.2B OF THE REPORT, ALTHOUGH THE CORRECT PRODUCT CODE FOR THE DEVICE IS QHT. THIS SUPPLEMENTAL REPORT IS FOR THE PURPOSE OF CORRECTING THE PRODUCT CODE.

    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. MXP2199027, QERTS# 462794.

    Description of Event or Problem · 1

    CUSTOMER REPORTS (B)(6) ANTIBODY ID RESULTS WERE OBTAINED WITH LOT VRB265 EXP 12/31/19 WHILE TESTING A PATIENT PREVIOUSLY KNOWN TO HAVE ANTI BIG C. THE PATIENT HISTORICALLY HAD ANTI BIG C AND AN ANTI JKA. AS OF (B)(6) 2019, BOTH HAD FALLEN BELOW DETECTABLE LEVELS. ON (B)(6) 2019 THE PATIENT WAS ADMITTED TO AN ASSOCIATED SITE AND USING THE COMPETITOR'S ANALYZER, THE ANTIBODY SCREEN WAS POSITIVE. A MANUAL GEL IDENTIFICATION TEST WAS DONE AND THEY IDENTIFIED ANTI BIG C AND AN "UNIDENTIFIED ANTIBODY". HE WAS TRANSFUSED 2 UNITS OF BLOOD AT THAT TIME AT THE ASSOCIATED SITE. ON (B)(6) 2019 ANOTHER ANTIBODY SCREEN TEST WAS DONE AT THE ASSOCIATED SITE. THE STRENGTH OF THE REACTIONS ON THE COMPETITOR'S ANALYZER WERE AS FOLLOWS: CELL 1 3+ CELL 2 1+ CELL 3 2+. THE ANTIBODY IDENTIFICATION TEST WAS NOT REPEATED SINCE THAT SITE RELIES ON TESTING RESULTS FROM (B)(6) 2019 AND CONSIDER IT VALID FOR 28 DAYS. TWO UNITS OF PACKED RED BLOOD CELLS WERE TRANSFUSED ON (B)(6) 2019 WITH NO ISSUES. NO PLASMA OR PLATELETS WERE TRANSFUSED. ON (B)(6) 2019 THE PATIENT WAS TRANSPORTED TO THIS CUSTOMER SITE AND TESTED ON VISION 50003068 (SAMPLE ID: EE-AF-05-50-1A-8B-94-90-29-28-5F-6D-88-48-AF-57-8B-82-01-EC-CD-A6-2B-AF-65-1A-7D-E1-E8-9F-0A-3E). THE ANTIBODY SCREEN RESULT WAS NEGATIVE. IT WAS TESTED ON THEIR OTHER VISION 50003069 AND RESULTS WERE ALSO (B)(6). FURTHER CONFIRMATION THAT THERE WERE NO ANTIBODIES, 0.8% RESOLVE PANEL B LOT VRB265 WAS LOADED ON VISION 50003069 AND TESTED ON THIS SAMPLE. ALL ELEVEN CELLS AND THE AUTOCONTROL WERE NEGATIVE. A NEW SAMPLE WAS DRAWN TO CONFIRM RESULTS (SAMPLE ID: 1D-F8-94-19-FB-3F-A1-1C-B7-FF-C0-ED-3A-35-CC-EE-0C-60-28-37-9E-77-22-84-E2-18-0C-04-EB-5C-F9-EA) AND TESTED ON VISION 50003069. THE ANTIBODY SCREEN RESULT WAS NEGATIVE. SINCE THIS WAS UNEXPECTED, THE CUSTOMER PERFORMED ADDITIONAL SCREENING TESTS ON THE FIRST SAMPLE BY TUBE METHOD USING COMPETITOR'S SCREENING CELLS, PEG AND OAES. ALL RESULTS WERE NEGATIVE. THEY DO NOT HAVE THE ORTHO WORKSTATION VALIDATED AND ARE UNABLE TO PERFORM MANUAL GEL TESTING. RELEVANT INFORMATION: ISSUE STARTED ON: (B)(6) 2019. MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: CELLS 18,19,20,22. REACTION GRADE OBTAINED: (B)(6). CUSTOMER WAS EXPECTING: POS TEST REPEATED: NO SAMPLE ID: SEE ECONN REPORT. NUMBER OF SAMPLES AFFECTED? TWO SAMPLES FROM THE SAME PATIENT. WAS QC AFFECTED? NO, VISION QC PASSED. ANTIGEN TYPING FOR BIG C ON CELLS WILL BE DONE AT A LATER TIME QC DATA: PASSED USING ALBAQ, SEE ECONN REPORT. PRODUCT HANDLING PROTOCOL: CASSETTE/GEL CARD STORAGE TEMPERATURE RANGE: AS PER IFU. CASSETTE/GEL CARD ORIENTATION: ACCEPTABLE. RBC STORAGE AND HANDLING: AS PER IFU. VISUAL APPEARANCE BEFORE USE: ACCEPTABLE. OPENED VS UNOPENED? OPENED. TROUBLESHOOTING STEPS PERFORMED BY TSC: ECONN DATA PULLED AND ANALYZED, IT CONFIRMED THE RESULTS WERE NOT FLAGGED AS QUESTIONABLE AND WERE MODIFIED TO (B)(6). IMAGES WERE PUSHED BY THE CUSTOMER AND THEY APPEAR CLEARLY (B)(6). NO ISSUE WITH THE CAMERA NOTED. CUSTOMER DOES NOT SUSPECT ANALYZER ISSUES. ALL QC PASSED, OTHER PATIENT RESULTS HAVE BEEN AS EXPECTED. TSC FOLLOWED UP WITH THE CUSTOMER. CUSTOMER REPORTED SHE TESTED THE SCREENING CELLS TODAY WITH BIORAD ANTI BIG C ANTISERA AND THE BIG C ANTIGEN ON CELL 1 WAS 3+ (B)(6) AS EXPECTED. CELL 2 AND CELL 3 WERE (B)(6), MATCHING THE ANTIGRAM. SHE STATED SHE WILL NOT TEST THE RESOLVE PANEL B CELLS FOR THE BIG C ANTIGEN, SHE IS SATISFIED AND BELIEVES THE ISSUE TO BE SAMPLE RELATED, POSSIBLY RELATED TO THE TRANSFUSION RECEIVED DAYS PRIOR. TSC DISCUSSED THE LIMITATION OF PROCEDURE SECTION OF THE INSTRUCTIONS FOR USE WHICH STATES "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 (B)(6)." SHE WILL DISCUSS WITH HER MANAGER AND SHOULD ADDITIONAL QUESTIONS OR CONCERNS ARISE, SHE WILL CONTACT TSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41516 ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL B REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VRB265

    Patients

    Seq Age Sex Outcome Treatment
    1