BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION

    MDR report key: 8950723 · Received August 30, 2019

    Report

    Report Number
    2250051-2019-00044
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 17, 2019
    Report Date
    August 30, 2019
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019, FE ARRIVED ON SITE AND REPLACED THE TUBING FROM THE SYRINGE TO THE PROBE. FE REPLACE THE PIPA PROBE FOLLOWED BY FILLING LIQUID SYSTEM, THEN WEEKLY MAINTENANCE FOLLOWED BY DAILY PROBE MAINTENANCE. CUSTOMER RAN QC FOR VERIFICATION. THE CUSTOMER HAS MADE NO CLAIMS OF ANY REPORTED FALSE RESULTS BEING REPORTED AS A RESULT OF THIS CONCERN.

    Description of Event or Problem · 1

    ON (B)(4) 2018, CUSTOMER BECAME AWARE THAT THEY HAVE BEEN USING 0.1N HCL FOR DAILY MAINTENANCE INSTEAD OF 0.1M NAOH RECOMMENDED BY ORTHO SINCE (B)(4) 2019. 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
    746340 ORTHO VISION AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1