BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS ANALYZER

    MDR report key: 15636144 · Received October 19, 2022

    Report

    Report Number
    2250051-2022-00062
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 21, 2022
    Report Date
    October 19, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MXP2471690, QERTS# 514565. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS: (B)(6). DISCREPANT ABO FORWARD TYPING RESULTS FOR TWO PATIENTS. THE ASSIGNABLE CAUSE IS USER RELATED, THE CUSTOMER MISTAKENLY LABELLING THE SAMPLE FROM PATIENT 1 WITH A LABEL FOR PATIENT 2. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. BIASED RESULTS WERE REPORTED TO A CLINICIAN. THE PATIENTS WERE NOT HARMED. INVESTIGATION BY THE ORTHO TECHNICAL SUPPORT SPECIALIST (TST) ASSISTED WITH THE FINDINGS THAT THESE EVENTS ARE DUE TO USER ERROR, AND THAT NO ERRONEOUS RESULTS WERE OBTAINED FOR THE 2 PATIENTS. THE ASSIGNABLE CAUSE FOR THE DISCREPANT ABO FORWARD TYPING RESULTS IS USER RELATED, THE CUSTOMER MISTAKENLY LABELLING THE SAMPLE FROM PATIENT 1 WITH A LABEL FOR PATIENT 2. IN ANY CASE THERE WAS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENTS AND ANALYSER TO PERFORM AS INTENDED. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO FURTHER COMPLAINTS OF THIS TYPE HAVE BEEN RECEIVED FROM THE CUSTOMER SITE SINCE THE TIME OF THE REPORTED EVENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER COMPLAINED TO ORTHO AFTER OBTAINING WAS DESCRIBED AS DISCREPANT RESULTS FOR TWO PATIENT SAMPLES FOR ABO FORWARD TYPING USING AN ORTHO VISION ID-MTS ANALYSER. DATE OF EVENTS: (B)(6) 2022. COMPLAINANT/COMPLAINT REPORTER: (B)(6) - MEDICAL TECHNOLOGIST. REPORTED ON (B)(6) 2022 BY (B)(6) TO THE ORTHO CARE HELPDESK. REAGENTS: RESOLVE PANEL B (LOT NOT PROVIDED). SOFTWARE VERSION: 5.13.2. SAMPLE INFORMATION: PATIENT 1 SAMPLE ID: (B)(6). PATIENT 2 SAMPLE ID: (B)(6). THE CUSTOMER REPORTED THAT, ON (B)(6) 2022, THEY HAD TESTED A SAMPLE FROM PATIENT 1 (ID: (B)(6) FOR ABO FORWARD TYPING AND ANTIBODY SCREENING (REAGENTS USED NOT PROVIDED) ON THEIR ORTHO VISION ID-MTS ANALYSER, AND THAT THEY HAD OBTAINED AN O D(RH1) NEGATIVE BLOOD GROUP RESULT AND A POSITIVE ANTIBODY SCREENING RESULT FOR THIS PATIENT. THE CUSTOMER REPORTED THAT, ON (B)(6) 2022, THEY HAD TESTED A SAMPLE FROM PATIENT 2 (ID: (B)(6) FOR ANTIBODY IDENTIFICATION USING RESOLVE PANEL B (LOT NOT PROVIDED) USING THE SAME ANALYSER. IT IS UNDERSTOOD THAT THE CUSTOMER OBTAINED A NEGATIVE ANTIBODY IDENTIFICATION RESULT. NO FURTHER DETAIL IS AVAILABLE. THE CUSTOMER STATED THAT AT THIS POINT, THEY REALISED THAT A LABORATORY OPERATOR HAD MISLABELLED THE SAMPLE TUBE WITH PATIENT 2 DETAILS (ID: (B)(6), WHEN IT WAS IN FACT THE TUBE FOR PATIENT 1 (ID: (B)(6). THE CUSTOMER EXPLAINED THAT THEY AMENDED THE CORRECT LABELS TO THE CORRECT SAMPLES AND REPEATED TESTING. THE CUSTOMER REPORTED THAT, ON (B)(6) 2022, THEY HAD TESTED THE CORRECT SAMPLE FROM PATIENT 2 (ID: (B)(6) FOR ABO FORWARD TYPING AND ANTIBODY SCREENING, AND THAT THEY HAD OBTAINED A B(ABO2) D(RH1) POSITIVE BLOOD GROUP RESULT, AND A NEGATIVE ANTIBODY SCREENING RESULT. THE CUSTOMER REPORTED THAT AN INITIAL BIASED RESULT WAS REPORTED TO A CLINICIAN, HOWEVER THEY HAVE SINCE CORRECTED THESE PATIENT RESULTS AND THE CUSTOMER CONFIRMS THAT NO ADVERSE EVENTS WERE BROUGHT ABOUT BY THE CLINICIAN. THE CUSTOMER REPORTED THAT THE PATIENTS WERE NOT HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656286 ORTHO VISION ID-MTS ANALYZER AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown