BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2882253 · Received December 20, 2012

    Report

    Report Number
    1319681-2012-00249
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A PARTICULATE FILTER WAS INSTALLED IN PLACE OF A VAPOR ADSORPTION CARTRIDGE ON A VITROS ECIQ SYSTEM WHICH HAS THE POTENTIAL TO AFFECT SAMPLE RESULTS. THE ROOT CAUSE OF THE INCORRECT FILTER PLACEMENT WAS BECAUSE OCD PACKAGED PARTICULATE FILTERS IN VAC SALES CARTONS. THIS ISSUE WAS NOT DETECTED BY THE USER PRIOR TO USE. EXPECTED PERFORMANCE WAS OBTAINED FOLLOWING THE REPLACEMENT OF THE PARTICULATE FILTER WITH THE VAC ON THE VITROS ECIQ SYSTEM. THE ISSUE HAS BEEN COMMUNICATED TO CUSTOMERS THROUGH CUSTOMER LETTER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PARTICULATE FILTER WAS INSTALLED IN PLACE OF A VAPOR ADSORPTION CARTRIDGE ON A VITROS ECIQ SYSTEM. THE POTENTIAL FOR THE OCCURENCE OF BIASED RESULTS EXISTS UNDER THIS CONDITION. THESE RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1