BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GENT REAGENT

    MDR report key: 2653829 · Received July 12, 2012

    Report

    Report Number
    1319808-2012-00020
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Date of Event
    May 31, 2012
    Report Date
    July 12, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS GENT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE CUSTOMER DEPLETED THEIR INVENTORY OF VITROS GENT LOT 1512-07-1075, THEREFORE, NO ADDITIONAL PERFORMANCE TESTS WERE COMPLETED USING THE AFFECTED REAGENT LOT. OCD HAS RECEIVED NO RELATED CUSTOMER COMPLAINTS FOR VITROS GENT LOT 1512-07-1075 TO SUGGEST A REAGENT ISSUE. AN ALTERNATE LOT OF VITROS GENT REAGENT GENERATED ACCEPTABLE QUALITY CONTROL PERFORMANCE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE VITROS GENT REAGENT COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT AN ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS GENT QUALITY CONTROL RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. VALUES OF 5.44, 3.83, 4.70, AND 4.41 UG/ML WERE OBTAINED FROM THE BIORAD LEVEL 2 FLUID VERSUS THE EXPECTED VALUE OR 7.83 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 GENT DURING THE TIME FRAME OF THIS EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR'S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS GENT REAGENT IN-VITRO DIAGNOSTIC LCD ORTHO-CLINICAL DIAGNOSTICS 1512-07-1075

    Patients

    Seq Age Sex Outcome Treatment
    1