BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 8096012 · Received November 21, 2018

    Report

    Report Number
    2250051-2018-00116
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 21, 2018
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCORDANT NEGATIVE DIRECT ANTIGLOBULIN TESTING (DAT) REACTION FOR ONE PATIENT USING THE ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH AN ORTHO VISION BIOVUE ANALYZER DURING VALIDATION OF THE ANALYZER. MOST PROBABLE ROOT-CAUSE IS ASSOCIATED WITH A DISPENSING ISSUE AND WITH AN ANTIBODY BEING WEAK AND AT OR AROUND THE DETECTION LIMIT OF THE REAGENT AND TECHNIQUE USED. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). A CUSTOMER REPORTED WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE DIRECT ANTIGLOBULIN TESTING (DAT) RESULT FOR ONE PATIENT USING THE ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH AN ORTHO VISION BIOVUE ANALYZER DURING VALIDATION OF THE ANALYZER. DATE OF EVENT: (B)(6) 2018. COMPLAINANT: (B)(6). COMPLAINT REPORTER: MRS (B)(6) ¿ PRODUCT MANAGER (B)(4) (DISTRIBUTOR FOR ORTHO IN (B)(6)). REPORTED ON 25 OCTOBER 2018 BY MRS (B)(6) TO MRS (B)(6) WHO REPORTED IT ON THE SAME DAY TO ORTHO CARE. REAGENTS: ORTHO BIOVUE SYSTEM DAT/IDAT CASSETTE LOT DAT281A, EXPIRY DATE 07 APRIL 2019. SOFTWARE VERSION: 5.10.0. PATIENT¿S INFORMATION: SAMPLE ID (B)(6); FEMALE; O RHD POSITIVE; NEGATIVE ANTIBODY SCREENING. THE CUSTOMER REPORTED THAT ON (B)(6) 2018, WHILE VALIDATING THEIR ORTHO VISION BIOVUE ANALYZER, THEY HAD TESTED A PATIENT¿S SAMPLE FOR DAT USING ORTHO BIOVUE SYSTEM DAT/IDAT CASSETTE LOT DAT281A IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH BIOVUE ANTI-IGG REAGENT OF THE CASSETTE AND A POSITIVE REACTION (0.5+ REACTION STRENGTH) WITH BIOVUE ANTI-C3D/-C3B REAGENT OF THE CASSETTE. THE CUSTOMER REPORTED THAT THEY WERE EXPECTING A POSITIVE REACTION (0.5-1+ REACTION STRENGTH) WITH BIOVUE ANTI-IGG REAGENT OF THE CASSETTE. THE CUSTOMER REPORTED THAT THEY HAD TESTED THIS PATIENT¿S SAMPLE AS FOLLOWS USING THE SAME LOT OF ORTHO BIOVUE SYSTEM DAT/IDAT CASSETTES: ON (B)(6) 2018 WITH THEIR ORTHO AUTOVUE INNOVA (SERIAL NUMBER (B)(4)) AND THAT THEY HAD OBTAINED POSITIVE REACTIONS (0.5+ REACTION STRENGTH) WITH BIOVUE ANTI-IGG AND BIOVUE ANTI-C3D/-C3B REAGENTS OF THE CASSETTE. ON (B)(6) 2018 WITH THEIR ORTHO AUTOVUE INNOVA (SERIAL NUMBER (B)(4)) AND THAT THEY HAD OBTAINED POSITIVE REACTIONS (0.5+ REACTION STRENGTH) WITH BIOVUE ANTI-IGG AND BIOVUE ANTI-C3D/-C3B REAGENTS OF THE CASSETTE. ON (B)(6) 2018 WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED AN INDETERMINATE REACTION WITH BIOVUE ANTI-IGG REAGENT OF THE CASSETTE AND A POSITIVE REACTION (0.5+ REACTION STRENGTH) WITH BIOVUE ANTI-C3D/-C3B REAGENT OF THE CASSETTE. ON (B)(6) 2018 WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A "TOO FEW CELLS" ERROR CODE WITH BIOVUE ANTI-IGG REAGENT OF THE CASSETTE AND A POSITIVE REACTION (0.5+ REACTION STRENGTH) WITH BIOVUE ANTI-C3D/-C3B REAGENT OF THE CASSETTE. ON (B)(6) 2018 WITH THEIR ORTHO AUTOVUE INNOVA (SERIAL NUMBER (B)(4)) AND THAT THEY HAD OBTAINED A POSITIVE REACTION (1+ REACTION STRENGTH) WITH BIOVUE ANTI-IGG REAGENT OF THE CASSETTE AND A POSITIVE REACTION (0.5+ REACTION STRENGTH) WITH BIOVUE ANTI-C3D/-C3B REAGENT OF THE CASSETTE. ON (B)(6) 2018 WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A "TOO FEW CELLS" ERROR CODE WITH BIOVUE ANTI-IGG REAGENT OF THE CASSETTE AND A POSITIVE REACTION (0.5+ REACTION STRENGTH) WITH BIOVUE ANTI-C3D/-C3B REAGENT OF THE CASSETTE. ON (B)(6) 2018 WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A "TOO FEW CELLS" ERROR CODE WITH BIOVUE ANTI-IGG REAGENT OF THE CASSETTE, A POSITIVE REACTION (2+ REACTION STRENGTH) WITH BIOVUE ANTI-C3D/-C3B REAGENT AND A POSITIVE REACTION (0.5+ REACTION STRENGTH) WITH THE CONTROL COLUMN OF THE CASSETTE. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN AND THAT THE PATIENT CONCERNED HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934501 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1