BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GENT REAGENT

    MDR report key: 2658372 · Received July 17, 2012

    Report

    Report Number
    1319808-2012-00022
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    May 9, 2012
    Report Date
    July 17, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS GENT PROFICIENCY RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT MALFUNCTION CONTRIBUTED TO THE EVENT. ACCEPTABLE RESULTS WERE OBTAINED USING THE SAME VITROS GENT REAGENT LOT WHEN THE PROFICIENCY SAMPLES WERE REPEATED AT A LATER DATE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, AN ISSUE WITH THE VITROS GENT REAGENT, THE FS DILUENT PACK 2, OR IMPROPER SAMPLE HANDLING COULD NOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. OCD HAS RECEIVED NO RELATED CUSTOMER COMPLAINTS FOR VITROS GENT LOT 1512-07-1283 TO SUGGEST A PRODUCT ISSUE. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS GENT PROFICIENCY RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. A VALUE OF 5.7 G/ML WAS OBTAINED FROM PROFICIENCY SAMPLE T67 VERSUS THE EXPECTED VALUE OF 8.3 G/ML. A VALUE OF 9.2 G/ML WAS OBTAINED FROM PROFICIENCY SAMPLE T68 VERSUS THE EXPECTED VALUE OF 14.0 G/ML. A VALUE OF 9.7 G/ML WAS OBTAINED FROM PROFICIENCY SAMPLE T70 VERSUS THE EXPECTED VALUE OF 15.3 G/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. 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 GENT REAGENT IN-VITRO DIAGNOSTIC LCD ORTHO-CLINICAL DIAGNOSTICS 1512-07-1283

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.