BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION

    MDR report key: 7924034 · Received October 1, 2018

    Report

    Report Number
    2250051-2018-00087
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    October 26, 2017
    Report Date
    October 1, 2018
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO CARE CONFIRMED THAT THERE WERE NO REPORTS OF ANY DISCREPANCIES WITH QC RESULTS OR PATIENT RESULTS. THE CUSTOMER MADE THE CORRECTIONS TO THEIR INTERNAL PROCEDURES TO PERFORM THE DAILY MAINTENANCE WITH 0.1M OF NAOH. THE CUSTOMER HAS MADE NO CLAIMS OF ANY REPORTED FALSE RESULTS BEING REPORTED AS A RESULT OF THIS CONCERN. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, CUSTOMER BECAME AWARE THAT THEY HAVE BEEN USING 1N NAOH FOR DAILY MAINTENANCE INSTEAD OF 0.1M RECOMMENDED BY ORTHO SINCE THE INSTALLATION OF THE VISION BACK IN (B)(6) 2017. ORTHO CARE DISCUSSED WITH CUSTOMER THE POTENTIAL FOR CARRYOVER WHEN NOT DOING THE DAILY DECONTAMINATION OF THE PROBE WITH 0.1M NAOH. ORTHO CARE CONFIRMED THAT THERE WERE NO REPORTS OF ANY DISCREPANCIES WITH QC RESULTS OR PATIENT RESULTS. THE CUSTOMER MADE THE CORRECTIONS TO THEIR INTERNAL PROCEDURES TO PERFORM THE DAILY MAINTENANCE WITH 0.1M OF NAOH THE CUSTOMER HAS MADE NO CLAIMS OF ANY REPORTED FALSE RESULTS BEING REPORTED AS A RESULT OF THIS CONCERN. ORTHO CARE ADVISED THE CUSTOMER TO CONTACT THEIR INTERNAL QUALITY DEPARTMENT OR MEDICAL DIRECTOR FOR ADVICE REGARDING TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764943 ORTHO VISION AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1