BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2061068 · Received April 18, 2011

    Report

    Report Number
    1319681-2011-00089
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT LOWER THAN EXPECTED VITROS VALP, VANC, AND TOBRA QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS AN INSTRUMENT RELATED ISSUE. ROUTINE MAINTENANCE BY THE CUSTOMER (REPLACEMENT OF THE PHOTOMETER LAMP) RETURNED THE INSTRUMENT TO EXPECTED OPERATION. THERE IS NO EVIDENCE THAT THE VITROS VALP, VANC, AND TOBRA REAGENTS MALFUNCTIONED. PERFORMANCE TESTING FOLLOWING MAINTENANCE DEMONSTRATED THAT THE INSTRUMENT WAS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VALP, VANC, AND TOBRA QUALITY CONTROL RESULTS WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENTS WERE TO RECUR WITH PATIENT SAMPLES. NO DISCREPANT VALP, VANC, OR TOBRA PATIENT RESULTS WERE REPORTED FROM THE LABORATORY TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1