BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS TOBRA REAGENT

    MDR report key: 8339392 · Received February 14, 2019

    Report

    Report Number
    1319808-2019-00006
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 14, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT HIGHER THAN EXPECTED VITROS TOBRAMYCIN (TOBRA) RESULTS WERE OBTAINED FROM A HIGH LEVEL CALIBRATOR FLUID PROCESSED USING A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CALIBRATOR FLUID WAS DILUTED AND TESTED AS PART OF AN INVESTIGATION FOR AN ISSUE WITH HIGH DILUTED TOBRA RESULTS ON MULTIPLE CAP PROFICIENCIES. THE HIGHER THAN EXPECTED RESULTS FOR DILUTED SAMPLES HAVE OCCURRED ACROSS MULTIPLE VITROS TOBRA LOTS OF REAGENT OVER TIME. ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD SUGGEST THERE IS A SYSTEMIC ISSUE WITH VITROS TOBRA REAGENT LOT 1513-03-5038. THE ASSIGNABLE CAUSE IS NOT LIKELY TO BE RELATED TO A SPECIFIC REAGENT LOT OR CALIBRATION EVENT. AN INSTRUMENT ISSUE OR AN ISSUE RELATED TO THE ON-BOARD DILUTION CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS TOBRAMYCIN (TOBRA) RESULTS FROM A HIGH LEVEL CALIBRATOR FLUID PROCESSED USING A VITROS 5600 INTEGRATED SYSTEM. CALIBRATOR KIT LOT 1428, BOTTLE 6 RESULTS 14.0, 14.3 UG/ML VERSUS AN EXPECTED RESULT OF 10.4, 10.6 UG/ML. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE OBTAINED OR REPORTED FROM THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT DEFINITIVELY CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131273 VITROS CHEMISTRY PRODUCTS TOBRA REAGENT IN-VITRO DIAGNOSTIC LDO ORTHO-CLINICAL DIAGNOSTICS 1513-05-6924

    Patients

    Seq Age Sex Outcome Treatment
    1