BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS OP REAGENT

    MDR report key: 2797819 · Received October 19, 2012

    Report

    Report Number
    1319808-2012-00036
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A CUSTOMER OBTAINED UNEXPECTED REPEATABLE DISCORDANT VITROS OP RESULTS WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST AN INSTRUMENT OR REAGENT MALFUNCTION HAD OCCURRED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THE POSSIBILITY THAT A NEGATIVE BIAS EXISTS WITH VITROS OP ASSAY WHEN COMPARED TO THE ALTERNATE (GC/MS) METHOD CANNOT BE RULED OUT. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED UNEXPECTED REPEATABLE DISCORDANT VITROS OP RESULTS (230, 232 NG/ML VS. AN EXPECTED RESULT > 300 NG/ML) FOR SINGLE PATIENT SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING THAT DETECTED THE PRESENCE OF OPIATES. 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 OP REAGENT IN-VITRO DIAGNOSTIC DJG ORTHO-CLINICAL DIAGNOSTICS 1527-07-1977

    Patients

    Seq Age Sex Outcome Treatment
    1