BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 2142079 · Received June 28, 2011

    Report

    Report Number
    1319681-2011-00138
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION OF THE EVENT, THE CUSTOMER CONFIRMED THAT A CREAT REAGENT CARTRIDGE WAS LOADED INTO THE SLIDE SUPPLY POSITION THAT HAD BEEN INCORRECTLY IDENTIFIED AS CONTAINING AN ECO2 REAGENT CARTRIDGE. ACCEPTABLE ECO2 RESULTS WERE OBTAINED AFTER THE CUSTOMER CORRECTLY LOADED AN ECO2 CARTRIDGE IN THE SLIDE SUPPLY POSITION. NO MALFUNCTION OCCURRED. THE VITROS 350 SYSTEM OPERATED AS PROGRAMMED AND INTENDED. THE ASSIGNABLE CAUSE OF THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED, BIASED RESULTS FOR MULTIPLE PATIENT AND QUALITY CONTROL SAMPLES PROCESSED FOR THE VITROS ECO2 ASSAY ON A VITROS 350 CHEMISTRY SYSTEM. VALUES OF <5.0 MMOL/L WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES, AND VITROS PERFORMANCE VERIFIER FLUIDS LOT Q9939 AND R9941. THE CUSTOMER DETERMINED THAT THE RESULTS WERE PROCESSED FROM A VITROS CHEMISTRY PRODUCTS CREA SLIDE CARTRIDGE. IT IS UNKNOWN IF ANY VITROS ECO2 RESULTS OF <5.0 MMOL/L WERE REPORTED OUTSIDE THE LABORATORY, HOWEVER, ALL AFFECTED PATIENT SAMPLES WERE RETESTED ON AN ALTERNATE VITROS 5600 SYSTEM ON SITE AND THE CORRECT ECO2 RESULTS WERE REPORTED FROM THE 5600 SYSTEM. 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 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1