BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2923212 · Received January 18, 2013

    Report

    Report Number
    1319681-2013-00033
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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). THE FDA'S (B)(4) DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON 20-DECEMBER-2012 PER RECALL NUMBER 1319681-12/20/2012-001-C.

    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. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27960 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNOASSAY SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1