BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS ANALYZER

    MDR report key: 13307974 · Received January 20, 2022

    Report

    Report Number
    2250051-2022-00002
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    January 5, 2022
    Report Date
    January 20, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MXP2408087. QERTS# 502016. EMAIL ADDRESS FOR CONTACT OFFICE (B)(6). FALSE NEGATIVE FORWARD TYPING FOR ONE PATIENT WAS REPORTED TO A CLINICIAN. THE ASSIGNABLE CAUSE IS USER ERROR WHERE THE CUSTOMER SCANNED A BARCODE OF ONE SAMPLE AND THEN PHYSICALLY LOADED A DIFFERENT SAMPLE INTO THAT POSITION. THE REPORTED BIASED RESULTS WERE CORRECTED PRIOR TO ANY FURTHER ACTION TAKEN. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. NO PATIENT WAS HARMED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A SINGLE PATIENT PRODUCED A FALSE BLOOD GROUP OF O POS WHEN TESTED IN THE ABD/REV CARD ON VISION ANALYZER ON (B)(6) 2022. PATIENT HAD A HISTORY OF BLOOD TYPE AB POSITIVE. CUSTOMER TESTED ANOTHER SAMPLE FROM THE SAME PATIENT FOR AN ABO CONFIRMATION WHICH RESULTED IN THE EXPECTED AB POS. THIS PROMPTED CUSTOMER TO REPEAT TESTING ON INITIAL PATIENT SAMPLE AND AB POS RESULTS ATTAINED. CUSTOMER REPORTS ALBA Q QC LOT# V242465; (B)(6) 2022 NOT AFFECTED. SW: 5.12.4 SAMPLE ID: (B)(6). ECONN ENCRYPTION ID # (B)(6). REPEAT TESTING ON VISION GAVE AB POS RESULTS USING THE SAME LISTED REAGENTS. CUSTOMER TESTED WITH MTS ABD/REV GEL CARD LOT# 080421037-06 EXP: 5.19.22, . CUSTOMER TESTED WITH 0.8% AFFIRMAGEN LOT# AFFIRMAGEN 8A374 EXP: 1.25.22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484860 ORTHO VISION ID-MTS ANALYZER AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown