BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 11700767 · Received April 21, 2021

    Report

    Report Number
    2250051-2021-00024
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 27, 2021
    Report Date
    April 21, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DISCREPANT NEGATIVE REACTION IN ANTIBODY IDENTIFICATION FOR ONE PROFICIENCY SAMPLE CONTAINING AN ANTI-E(RH3) ANTIBODY. THE ROOT CAUSE COULD NOT BE DETERMINED. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO THE PROFICIENCY SUPPLIER. NO PATIENT WAS HARMED. (B)(4)

    Description of Event or Problem · 0

    ORTHO HAS OBSERVED WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE REACTION IN ANTIBODY IDENTIFICATION FOR ONE PROFICIENCY SAMPLE USING THE ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYZER. DATE OF EVENT: (B)(6) 2021 COMPLAINANT/COMPLAINT REPORTER: (B)(6)¿ ORTHO SENIOR SCIENTIST REPORTED ON 31 MARCH 2021 BY (B)(6) TO ORTHO CARE HELPDESK REAGENTS: ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC096H EXPIRY DATE 07 JUNE 2021 (MANUFACTURED 10 OCTOBER 2020) 0.8% RESOLVE PANEL C LOT 8RC366 EXPIRY DATE 11 MAY 2021 (MANUFACTURED 23 FEBRUARY 2021) ORTHO BIOVUE SYSTEM NEUTRAL CASSETTE LOT NEC033F EXPIRY DATE 31 AUGUST 2021 (MANUFACTURED 05 SEPTEMBER 2020) 0.8% RESOLVE PANEL C LOT 8RC365 EXPIRY DATE 13 APRIL 2021 (MANUFACTURED 26 JANUARY 2021) 0.8% BIOVUE SCREEN LOT BVS364 EXPIRY DATE 14 APRIL 2021 (MANUFACTURED 21 JANUARY 2021) SOFTWARE VERSION: 5.12.8 PROFICIENCY EXERCISE INFORMATION: (B)(6) EXERCISE 21E3; DISTRIBUTION DATE: 22 MARCH 2021; CLOSING DATE: 01 APRIL 2021 FOUR PATIENT SAMPLES ARE PROVIDED FOR ANTIBODY SCREENING/IDENTIFICATION. FROM (B)(6) EXERCISE SUMMARY REPORT: PATIENT 1 - ANTI-D: TITRE 16 VS. R1R CELLS PATIENT 2 - ANTI-D+E: ANTI-D TITRE 2 VS R1R CELLS AND ANTI-E TITRE 1 VS R''R CELLS PATIENT 3 - INERT PATIENT 4 - ANTI-D: (B)(6) 'STANDARD', TITRE 0 VS. R1R CELLS TITRES OBTAINED BY TUBE LISS SUSPENSION IN THE (B)(6) LABORATORY ON THE CLOSING DATE AN ORTHO PERSONNEL REPORTED THAT ON (B)(6) 2021, PATIENT SAMPLE 2 FROM (B)(6) PROFICIENCY EXERCISE 21E3 WAS TESTED FOR ANTIBODY SCREENING IN THE INDIRECT ANTIGLOBULIN TEST (IAT) AND ENZYME METHOD USING 0.8% BIOVUE SCREEN LOT BVS364, ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC096H AND ORTHO BIOVUE SYSTEM NEUTRAL CASSETTE LOT NEC033F IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED: - POSITIVE REACTIONS (2+ REACTION STRENGTH) WITH CELLS 1 AND 2 AND A NEGATIVE REACTION WITH CELL 3 OF THE RED CELL REAGENT IN IAT - POSITIVE REACTIONS (3+ REACTION STRENGTH) WITH CELLS 1 AND 2 AND A NEGATIVE REACTION WITH CELL 3 OF THE RED CELL REAGENT IN FICIN-ENZYME TECHNIQUE. THE ORTHO PERSONNEL REPORTED THAT ON THE SAME DAY, PATIENT SAMPLE 2 FROM (B)(6) PROFICIENCY EXERCISE 21E3 WAS TESTED FOR ANTIBODY IDENTIFICATION IN THE INDIRECT ANTIGLOBULIN TEST (IAT) AND ENZYME METHOD USING 0.8% RESOLVE PANEL C LOT 8RC366, THE SAME LOTS OF ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE AND OF ORTHO BIOVUE SYSTEM NEUTRAL CASSETTE AND THE SAME ANALYZER AND THAT THEY HAD OBTAINED: - POSITIVE REACTIONS (2+ REACTION STRENGTH) WITH CELLS 1, 2, 3 AND 4, A POSITIVE REACTION (1+ REACTION) WITH CELL 11 AND NEGATIVE REACTIONS WITH THE OTHER 6 CELLS OF THE RED CELL REAGENT IN IAT - POSITIVE REACTIONS (3+ REACTION STRENGTH) WITH CELLS 1, 2, 3, 4, 6 AND 11, AND NEGATIVE REACTIONS WITH THE OTHER 5 CELLS OF THE RED CELL REAGENT IN FICIN-ENZYME TECHNIQUE. THE ORTHO PERSONNEL REPORTED THAT THE LABORATORY OPERATOR HAD CONCLUDED TO THE PRESENCE OF AN ANTI-D(RH1) ANTIBODY AND OF AN ANTI-E(RH3) ANTIBODY REACTING IN ENZYME TECHNIQUE ONLY. ON (B)(6) 2021, THE ORTHO PERSONNEL REQUESTED ADDITIONAL TESTING DUE THE UNUSUAL PRESENCE OF MULTIPLE ANTI-D(RH1) ANTIBODIES IN THE SAMPLES PROVIDED (3 OF 4 (B)(6) SAMPLES). THE ORTHO PERSONNEL REPORTED THAT ON (B)(6) 2021, PATIENT SAMPLE 2 FROM (B)(6) PROFICIENCY EXERCISE 21E3 WAS RE-TESTED FOR ANTIBODY IDENTIFICATION IN THE INDIRECT ANTIGLOBULIN TEST (IAT) AND ENZYME METHOD USING 0.8% RESOLVE PANEL C LOT 8RC365, THE SAME LOTS OF ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE AND OF ORTHO BIOVUE SYSTEM NEUTRAL CASSETTE IN MANUAL METHOD AND THAT THEY HAD OBTAINED: - POSITIVE REACTIONS (2+ REACTION STRENGTH) WITH CELLS 1, 2, 3, 4, 6 AND 11 AND NEGATIVE REACTIONS WITH THE OTHER 5 CELLS OF THE RED CELL REAGENT IN IAT - POSITIVE REACTIONS (3+ REACTION STRENGTH) WITH CELLS 1, 2, 3, 4, 6 AND 11, AND NEGATIVE REACTIONS WITH THE OTHER 5 CELLS OF THE RED CELL REAGENT IN FICIN-ENZYME TECHNIQUE. THE ORTHO PERSONNEL REPORTED THAT ON THE SAME DAY, PATIENT SAMPLE 2 FROM (B)(6) PROFICIENCY EXERCISE 21E3 WAS RE-TESTED FOR ANTIBODY IDENTIFICATION IN THE INDIRECT ANTIGLOBULIN TEST (IAT) AND ENZYME METHOD USING CELL 6 OF 0.8% RESOLVE PANEL C LOT 8RC366, THE SAME LOTS OF ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE AND OF ORTHO BIOVUE SYSTEM NEUTRAL CASSETTE IN MANUAL METHOD AND THAT THEY HAD OBTAINED: - A POSITIVE REACTION (0.5+ REACTION STRENGTH) IN IAT - A POSITIVE REACTION (3+ REACTION STRENGTH) IN FICIN-ENZYME TECHNIQUE. THE ORTHO PERSONNEL REPORTED THAT THEY WERE ABLE TO IDENTIFY A MIX OF ANTI-D(RH1) AND ANTI-E(RH3) ANTIBODIES. THE ORTHO PERSONNEL SAID THAT NO BIASED RESULT HAD BEEN REPORTED TO THE PROFICIENCY SUPPLIER. THE ORTHO PERSONNEL REPORTED THAT NO PATIENT WAS HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599569 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1