BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION MAX

    MDR report key: 9341349 · Received November 19, 2019

    Report

    Report Number
    2250051-2019-00055
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    September 19, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT POSITIVE WEAK D(RH1) ANTIGEN TYPING RESULTS FOR MULTIPLE PATIENT SAMPLES. THE ROOT CAUSE COULD NOT BE DETERMINED, ALTHOUGH IT COULD NOT BE EXCLUDED TO BE ASSOCIATED WITH CONTAMINATION WITHIN THE ORTHO VISION MAX BIOVUE ANALYSER SYSTEM. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. A BIASED RESULT WAS REPORTED TO A PHYSICIAN. NO PATIENT WAS HARMED AS A RESULT OF THE REPORT EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER IS REPORTING DISCREPANT POSITIVE WEAK D(RH1) ANTIGEN TYPING RESULTS FOR MULTIPLE PATIENTS USING ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISON MAX BIOVUE ANALYSER. COMPLAINANT: MS (B)(6) - TECHNICAL MANAGER. COMPLAINT REPORTER: MS (B)(6)- ORTHO LABORATORY SPECIALIST. REPORTED ON: (B)(6) 2019 BY MS (B)(6) TO MS (B)(6) WHO REPORTED IT TO THE ORTHOCARE HELPDESK ON (B)(6) 2019. DATE OF EVENTS: (B)(6) 2019. SOFTWARE VERSION: (B)(4). REAGENTS: ORTHO SERA ANTI-D(IAT)-BV LOT V200683 EXPIRY DATE 17 NOVEMBER 2020. ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC740A EXPIRY DATE 02 JANUARY 2020. PATIENT INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT THEY HAD TESTED MULTIPLE PATIENT SAMPLES FOR WEAK D(RH1) ANTIGEN TYPING USING ORTHO SERA ANTI-D(IAT) REAGENT LOT V200683 AND ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC740A IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER AND THAT THEY OBTAINED THE FOLLOWING RESULTS: (B)(4). THE CUSTOMER REPORTED THAT A BIASED RESULT WAS REPORTED TO A PHYSICIAN. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT NO PATIENT HAD BEEN HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140187 ORTHO VISION MAX AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1