BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GENT REAGENT

    MDR report key: 4021414 · Received August 19, 2014

    Report

    Report Number
    1319808-2014-00020
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE VITROS GENT RESULTS WERE OBTAINED ON THREE DIFFERENT QUALITY CONTROL FLUIDS PROCESSED ON A VITROS 5,1FS CHEMISTRY SYSTEM. THE MOST LIKELY CAUSE FOR THIS EVENT IS RELATED TO VITROS GENT REAGENT LOT 1512-09-3511, AS NON-REPRODUCIBLE LOWER THAN EXPECTED RESULTS WERE OBTAINED USING THREE PARTICULAR REAGENT PACKS FROM LOT 1512-09-3511. THERE IS NO INDICATION THAT THE VITROS 5,1FS INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT. THE ASSIGNABLE CAUSE FOR THE EVENT IS RELATED TO VITROS GENT REAGENT LOT 1512-09-3511.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS GENT RESULTS ON THREE DIFFERENT QUALITY CONTROL FLUIDS PROCESSED ON A VITROS 5,1FS CHEMISTRY SYSTEM USING VITROS GENT REAGENT, LOT 1512-09-3511.TDM LEV I VITROS GENT= 0.763 AND 0.739 VERSUS EXPECTED 2.73 UG/ML. BIORAD LEV 2 VITROS GENT= 3.4 VERSUS EXPECTED 5.3 UG/ML. BIORAD LEV 3 VITROS GENT = 5.0 VERSUS EXPECTED 7.9 UG/ML.BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. HOWEVER, NO VITROS GENT PATIENT SAMPLE RESULTS WERE QUESTIONED. THERE WAS NO ALLEGATION 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498170 VITROS CHEMISTRY PRODUCTS GENT REAGENT IN-VITRO DIAGNOSTIC LCD ORTHO-CLINICAL DIAGNOSTICS 1512-09-3511

    Patients

    Seq Age Sex Outcome Treatment
    1