BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT

    MDR report key: 3204054 · Received July 3, 2013

    Report

    Report Number
    3007111389-2013-00129
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE RUN ON A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS METHOD RESULT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THERE WAS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN UNKNOWN SAMPLE INTERFERENT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULTS (0.28, 0.274 VS. AN EXPECTED RESULT = 4.93 MIU/L) FROM A SINGLE PATIENT SAMPLE RUN ON A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS METHOD RESULT. THE AFFECTED PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER RETESTED THE SAMPLE USING A NON-VITROS METHOD AS THE PHYSICIAN QUESTIONED THE RESULT. A CORRECTED REPORT WAS NOT ISSUED AS THE PHYSICIAN WAS ABLE TO ACCESS THE EXPECTED RESULT USING THE HOSPITAL PORTAL. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304536 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4240

    Patients

    Seq Age Sex Outcome Treatment
    1