BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 2825447 · Received November 8, 2012

    Report

    Report Number
    1319808-2012-00037
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VANC QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE ISSUE APPEARED TO BE ISOLATED TO A SINGLE VITROS VANC REAGENT PACK, AS THE LOWER THAN EXPECTED RESULTS WERE ASSOCIATED WITH THE INTRODUCTION OF THE AFFECTED PACK. THE CUSTOMER REPLACED THE VITROS VANC REAGENT PACK WITH AN ALTERNATE VANC REAGENT PACK FROM THE SAME LOT, AND ACCEPTABLE PERFORMANCE WAS OBSERVED. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST AN INSTRUMENT MALFUNCTION OCCURRED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE INVESTIGATION DETERMINED THAT THE EVENT WAS RELATED TO THE SPECIFIC VITROS VANC REAGENT PACK IN USE AT THE TIME OF THE EVENT. AT THIS TIME, OCD HAS NOT RECEIVED ANY RELATED COMPLAINTS FOR VITROS VANC LOT 2514-23-2043 TO SUGGEST A PRODUCT QUALITY ISSUE WITH THE REAGENT LOT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VANC QUALITY CONTROL RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. A VALUE OF < 5.0 UG/ML WAS OBTAINED FROM THE VITROS TDM PV I FLUID VERSUS THE EXPECTED VALUE OF 8.128 UG/ML, AND A VALUE OF < 5.0 UG/ML WAS OBTAINED FROM THE VITROS TDM PV III FLUID VERSUS THE EXPECTED VALUE OR 38.000 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE RUN FOR VITROS VANC WHILE THE QUALITY CONTROL RESULTS WERE OUTSIDE OF EXPECTED RANGES. 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 CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTIC LEH ORTHO-CLINICAL DIAGNOSTICS 2514-23-2043

    Patients

    Seq Age Sex Outcome Treatment
    1