BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 12120473 · Received July 6, 2021

    Report

    Report Number
    2250051-2021-00045
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 6, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISCORDANT NEGATIVE GRADING OF ANTIBODY SCREENING REACTIONS FOR ONE PATIENT KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY. THE DISCREPANT NEGATIVE GRADING FOR THE ANTIBODY SCREENING REACTIONS AS REPORTED BY THE CUSTOMER WERE NOT CONFIRMED. THE ORTHO VISION® BIOVUE AND ORTHO AUTOVUE® INNOVA ANALYZERS HAVE FUNCTIONED AS PER DESIGN. THE ROOT-CAUSE OF THE DISCORDANT NEGATIVE ANTIBODY SCREENING REACTIONS OBTAINED BY THE CUSTOMER COULD NOT BE CONFIRMED ALTHOUGH IT COULD NOT BE EXCLUDED THAT IT IS SAMPLE-RELATED, THE ANTI-E(RH3) ANTIBODY BEING WEAK AND/OR AT DETECTION LIMIT OF THE REAGENTS AND TECHNIQUES USED. NO PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED. (B)(4)

    Description of Event or Problem · 0

    A CUSTOMER COMPLAINED AFTER OBTAINING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE GRADING OF ANTIBODY SCREENING REACTIONS FOR ONE PATIENT USING ORTHO BIOVUE® SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISION® BIOVUE AND ORTHO AUTOVUE® INNOVA ANALYSERS. COMPLAINANT/COMPLAINT REPORTER: (B)(6), POSITION NOT PROVIDED EVENT DATES: (B)(6) 2021 REPORTED ON: 17 JUNE 2021 TO THE ORTHO CARE HELPDESK ANALYZERS: ORTHO VISION® BIOVUE J60002360 SOFTWARE VERSION 5.13.0 ORTHO AUTOVUE® INNOVA J31279 SOFTWARE VERSION 2.01 REAGENTS: 0.8% SURGISCREEN® (PRODUCT CODE 719102; LOT 8SS8111; EXPIRY DATE 05 JULY 2021, MANUFACTURING DATE 03 MAY 2021) ORTHO BIOVUE® SYSTEM AHG ANTI-IGG CASSETTE (PRODUCT CODE 707400; LOTS IGC104F AND IGC108J; EXPIRY DATES RESPECTIVELY 29 SEPTEMBER 2021 AND 15 NOVEMBER 2021; MANUFACTURING DATE RESPECTIVELY 01 FEBRUARY 2021 AND 20 MARCH 2021) PATIENT INFORMATION: KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY THE CUSTOMER SAID THAT ON (B)(6) 2021, THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SURGISCREEN® AND ORTHO BIOVUE® SYSTEM ANTI-IGG CASSETTE LOT IGC104F IN COMBINATION WITH THEIR ORTHO VISION® BIOVUE ANALYZER AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE THREE CELLS OF THE RED CELL REAGENT (COLUMNS 1, 2 AND 3 OF CASSETTE ID (B)(4)). THE CUSTOMER SAID THAT ON (B)(6) 2021, THEY HAD TESTED THE SAME SAMPLE FOR ANTIBODY SCREENING IN IAT USING THE SAME LOT OF 0.8% SURGISCREEN® AND ORTHO BIOVUE® SYSTEM ANTI-IGG CASSETTE LOT IGC108J IN COMBINATION WITH THEIR ORTHO AUTOVUE® INNOVA ANALYZER AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE THREE CELLS OF THE RED CELL REAGENT (COLUMNS 1, 2 AND 3 OF CASSETTE ID (B)(4)). THE CUSTOMER CONTACTED ORTHO CARE ON 17 JUNE 2021 TO STATE THAT UPON VISUAL INSPECTION OF THE CASSETTE IMAGES, THEY OBSERVED SOME AGGLUTINATION FOR COLUMNS 2 OF EACH CASSETTE CORRESPONDING TO CELL 2 OF 0.8% SURGISCREEN® LOT 8SS8111. THE CUSTOMER REPORTED THEY HAD TESTED THE SAME SAMPLE FOR ANTIBODY SCREENING IN IAT USING THE SAME LOT OF 0.8% SURGISCREEN® AND ORTHO BIOVUE® SYSTEM ANTI-IGG CASSETTE IN BIOVUE® MANUAL METHOD APPLYING AN INCUBATION TIME OF 30 MINUTES AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH CELLS 1 AND 3 AND A 0.5+ POSITIVE REACTION WITH CELL 2 OF THE RED CELL REAGENT AS EXPECTED. NO FURTHER DETAIL WAS PROVIDED. IT IS UNDERSTOOD THAT NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED BECAUSE OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016450 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1