BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION

    MDR report key: 8147567 · Received December 10, 2018

    Report

    Report Number
    2250051-2018-00142
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 10, 2018
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCORDANT NEGATIVE GRADING FOR ONE CROSS MATCH RESULT FOR ONE PATIENT HAVING AN ANTI-KPA (KEL3) ANTIBODY. THE DISCREPANT NEGATIVE REACTION IN CROSS MATCH TESTING WAS NOT CONFIRMED AS THE DONOR WAS NOT TYPED FOR KPA (KEL3) ANTIGEN; HOWEVER, CONSIDERING THE POSITIVE REACTION IN BIOVUE MANUAL TESTING WITH 0.5+ REACTION STRENGTH AND TAKING A CONSERVATIVE APPROACH, IT IS A POSSIBILITY TO HAVE A POTENTIAL MISSED WEAK REACTION IN CROSS MATCH TESTING WITH AN ANTI-KPA (KEL3) ANTIBODY. THE PROBABLE ROOT-CAUSE OF THE DISCREPANT GRADING OF THE REACTION IN CROSS MATCH TESTING WAS DUE TO A POOR FOCUS OF THE ORTHO VISION BIOVUE'S CIMS. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. NO PATIENT WAS HARMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE CROSS MATCH REACTION FOR ONE PATIENT USING THE ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH AN ORTHO VISION BIOVUE ANALYZER. DATE OF EVENT: (B)(6) 2018. COMPLAINANT NAME: MR (B)(6) - (B)(6). COMPLAINT REPORTER: MR (B)(4) ¿ ORTHO FIELD ENGINEER. REPORTED ON (B)(6) 2018 BY THE CUSTOMER TO ORTHO FIELD ENGINEER WHO REPORTED IT THE SAME DAY TO ORTHOCARE HELPDESK. REAGENTS: ORTHO BIOVUE SYSTEM ANTI-IGG CASSETTE LOT IGC723A EXPIRY DATE 27 APRIL 2019, MANUFACTURED ON 27 AUGUST 2018. 0.8% RED CELL DILUENT LOT RCD878 EXP. DATE 23 MAY 2019, MANUFACTURED ON 23 MAY 2018. SOFTWARE VERSION: 5.11.2. PATIENT¿S INFORMATION: PATIENT IS KNOWN TO HAVE A WEAK ANTI-KPA (KEL3) ANTIBODY. THE CUSTOMER SAID THAT THEY HAD TESTED THIS SAMPLE FOR ANTIBODY SCREENING OR/AND ANTIBODY IDENTIFICATION AND GOT A 1+ REACTION WITH RED CELL BEING KPA(KP3) ANTIGEN POSITIVE (NO FURTHER INFORMATION WAS PROVIDED). THE CUSTOMER IS REPORTING THAT THEY HAD TESTED A PATIENT'S SAMPLE FOR 0.8% MAJOR CROSSMATCH TESTING USING ORTHO BIOVUE ANTI-IGG CASSETTE LOT IGC723A AND 0.8% RED CELL DILUENT LOT RCD878 WITH AN ORTHO VISION BIOVUE ANALYZER AND THAT THEY OBTAINED A NEGATIVE REACTION WITH DONOR (B)(6) IN CASSETTE ID (B)(4), COLUMN 1. THE CUSTOMER SAID THAT WHEN LOOKING AT THIS CASSETTE IMAGE, THE REACTION IN COLUMN 1 WAS SLIGHTLY POSITIVE. THE CUSTOMER SAID THAT AT THE SAME MOMENT THE SAME PATIENT'S SAMPLE WAS TESTED FOR 0.8% MAJOR CROSSMATCH TESTING USING THE SAME REAGENT LOTS IN BIOVUE MANUAL TECHNIQUE AND THAT THE REACTION WAS POSITIVE WITH THE SAME DONOR IN CASSETTE ID (B)(4), COLUMN 2 . THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985336 ORTHO VISION AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1