BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2267952 · Received September 28, 2011

    Report

    Report Number
    1319681-2011-00181
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    August 30, 2011
    Report Date
    September 28, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVENT INVESTIGATION, THE CUSTOMER CONFIRMED THAT AN ALT REAGENT CARTRIDGE WAS LOADED INTO THE SLIDE SUPPLY POSITION THAT HAD BEEN INCORRECTLY IDENTIFIED BY THE USER AS CONTAINING AN AST REAGENT CARTRIDGE. ACCEPTABLE AST RESULTS WERE OBTAINED FOR EACH AFFECTED SAMPLE WHEN TESTED ON AN ALTERNATE VITROS SYSTEM. NO MALFUNCTION OCCURRED. THE VITROS 5,1 FS SYSTEM OPERATED AS PROGRAMMED AND INTENDED. THE ASSIGNABLE CAUSE OF THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED "NO RESULTS" WITH THE GENERATION OF A U90-351 (RESULT BELOW SPLINE RANGE) CONDITION CODE FOR MULTIPLE PATIENT SAMPLES PROCESSED FOR THE VITROS AST ASSAY ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE CUSTOMER DETERMINED THAT THE RESULTS WERE PROCESSED FROM A VITROS CHEMISTRY PRODUCTS ALT SLIDE CARTRIDGE. THE CUSTOMER DID NOT REPORT ANY ERRONEOUS AST PATIENT RESULTS, AS NO NUMERICAL AST RESULTS WERE OBTAINED FROM EACH AFFECTED SAMPLE. 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 JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.