BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS TOBRA REAGENT

    MDR report key: 5777200 · Received July 7, 2016

    Report

    Report Number
    1319808-2016-00013
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    June 12, 2016
    Report Date
    July 5, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED TOBRA QUALITY CONTROL RESULT WAS OBTAINED FROM A NON-VITROS QUALITY CONTROL FLUID USING VITROS TOBRA REAGENT WITH A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. VITROS GENT AND ALT PRECISION TESTING OF THE VITROS 5600 INTEGRATED SYSTEM WAS WITHIN ACCEPTANCE LIMITS, INDICATING THAT THE VITROS 5600 INTEGRATED SYSTEM WAS OPERATING AS INTENDED. HOWEVER PRECISION TESTING WAS PERFORMED FOLLOWING REPLACEMENT OF A COMPONENT, THEREFORE UNEXPECTED INSTRUMENT PERFORMANCE CANNOT BE ENTIRELY RULED OUT AS CONTRIBUTING TO THE EVENT. HISTORICAL QUALITY CONTROL DATA WAS ATYPICAL, INDICATING THAT A VITROS TOBRA REAGENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. PRE¿ANALYTICAL HANDLING OF THE NON-VITROS QC FLUID ALSO COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENTS AS INFORMATION REGARDING HANDLING PROTOCOLS WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A HIGHER THAN EXPECTED TOBRAMYCIN (TOBRA) QUALITY CONTROL RESULT (>10.0 UG/ML VERSUS EXPECTED RESULT OF 6.43 UG/ML) FROM A NON-VITROS QUALITY CONTROL FLUID USING VITROS TOBRA REAGENT WITH A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED TOBRA RESULTS WERE GENERATED FROM A NON-PATIENT FLUID AND NO ERRONEOUS PATIENT SAMPLE RESULTS WERE OBTAINED OR REPORTED FROM THE LABORATORY, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO OCCUR UNDETECTED. THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430996 VITROS CHEMISTRY PRODUCTS TOBRA REAGENT IN-VITRO DIAGNOSTIC LDO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1