BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION MAX ID-MTS ANALYZER

    MDR report key: 15077652 · Received July 21, 2022

    Report

    Report Number
    2250051-2022-00048
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 23, 2022
    Report Date
    July 21, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MXP32178230 QERTS# (B)(4). EMAIL ADDRESS FOR CONTACT OFFICE IN FIELDS ABOVE IS: (B)(6). THE ASSIGNABLE CAUSE IS ASSOCIATED TO A USE ERROR, A LABORATORY OPERATOR HAVING SWITCHED THE POSITIONS OF THE 2 SAMPLE CONTAINERS THAT HAD BEEN MANUALLY ASSIGNED. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENTS WERE NOT HARMED. CUSTOMER LETTER (B)(6).

    Description of Event or Problem · 0

    ON (B)(6)2022, A CUSTOMER CONTACTED ORTHO DISTRIBUTOR REPRESENTATIVE TO REPORT WHAT WAS DESCRIBED AS DISCORDANT ABO GROUPING FOR TWO PATIENTS USING THE ORTHO BIOVUE® SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISION® MAX BIOVUE ANALYZER J80002293 EQUIPPED WITH SOFTWARE VERSION 5.13.4. EVENTS DATE: 23 JUNE 2021. COMPLAINANT NAME: NOT PROVIDED. COMPLAINT REPORTER NAME: (B)(6) MEDICAL (DISTRIBUTOR FOR ORTHO IN SOUTH AFRICA) REAGENTS: ORTHO BIOVUE® SYSTEM ABO-RH/REVERSE GROUPING CASSETTE (PRODUCT CODE 707155; LOT ABR323F; EXPIRY DATE 12 NOVEMBER 2022; MANUFACTURING DATE 15 FEBRUARY 2022) AFFIRMAGEN® (PRODUCT CODE 707910; LOT 4A029Z; EXPIRY DATE 26 JULY 2022; MANUFACTURING DATE 24 MAY 2022.) PATIENTS¿ INFORMATION: PATIENT 1: SAMPLE ID (B)(6); KNOWN TO BE B RHD POSITIVE PATIENT 2: SAMPLE ID (B)(6); KNOWN TO BE A RHD POSITIVE. THE CUSTOMER REPORTED THAT, ON (B)(6)2022, THEY HAD TESTED SAMPLE ID (B)(6) FROM PATIENT 1 AND SAMPLE ID (B)(6) FROM PATIENT 2 FOR ABO/D GROUPING USING ORTHO BIOVUE® SYSTEM ABO-RH/REVERSE GROUPING CASSETTE AND AFFIRMAGEN® IN CONJUNCTION WITH THEIR ORTHO VISION® MAX BIOVUE ANALYZER J80002293 AND THAT THEY OBTAINED AN A RHD POSITIVE BLOOD GROUP FOR PATIENT A AND A B RHD POSITIVE BLOOD GROUP FOR PATIENT 2. THE CUSTOMER REPORTED THAT, ON THE SAME DAY, THEY HAD TESTED THE SAME SAMPLES FOR ABO/D GROUPING USING THE SAME LOTS OF ORTHO BIOVUE® SYSTEM ABO-RH GROUPING CASSETTE AND AFFIRMAGEN® IN CONJUNCTION WITH THEIR ALTERNATIVE ORTHO VISION® BIOVUE ANALYZER J60003325 AND THAT THEY OBTAINED A B RHD POSITIVE BLOOD GROUP FOR PATIENT A AND AN A RHD POSITIVE BLOOD GROUP FOR PATIENT 2. THE CUSTOMER REPORTED THAT THE RESULT OBTAINED WITH THEIR SECOND ANALYZER WERE AS EXPECTED. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENTS HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719472 ORTHO VISION MAX ID-MTS ANALYZER AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown