BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2241847 · Received September 9, 2011

    Report

    Report Number
    1319681-2011-00175
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 9, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS GENTAMICIN (GENT) RESULTS WERE OBTAINED FROM 2 LEVELS OF QUALITY CONTROL FLUIDS WHILE USING A VITROS 5,1 FS CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE WAS AN ANALYZER RELATED ISSUE. OCD FIELD SERVICE PERFORMED "AS NEEDED" SERVICE AND ADJUSTMENTS TO METERING AND THE MICROTIP INCUBATOR. GENT QUALITY CONTROL RESULTS WERE WITHIN EXPECTED RANGES AFTER SERVICE ACTION WERE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS GENTAMICIN (GENT) RESULTS FROM 2 LEVELS OF QUALITY CONTROL FLUIDS WHILE USING A VITROS 5,1 FS CHEMISTRY SYSTEM. DUPLICATE VALUES OF 5.36 UG/ML WERE OBTAINED FROM THE VITROS PERFORMANCE VERIFIER LOT W9389 FLUID VERSUS THE EXPECTED VALUE OF 1.20 UG/ML. DUPLICATE VALUES OF >10.0 UG/ML WERE OBTAINED FROM THE VITROS PERFORMANCE VERIFIER LOT Y9391 FLUID VERSUS THE EXPECTED VALUE OF 7.28 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE IS NO EVIDENCE THAT PATIENT SAMPLES WERE AFFECTED AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER LCD ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.