BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT

    MDR report key: 3000486 · Received March 12, 2013

    Report

    Report Number
    3007111389-2013-00062
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT AN OCD ANALYST OBTAINED A REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULTS DURING ROUTINE INTERNAL STABILITY TESTING RUN ON THE VITROS ECI SYSTEM. ROOT CAUSE FOR THE LOWER THAN EXPECTED RESULTS IS UNKNOWN, HOWEVER, A SUB-OPTIMAL CALIBRATION CURVE DUE TO THE USE OF EXPIRED PRODUCT CANNOT BE RULED OUT. INTERNAL INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AN OCD ANALYST OBTAINED A REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH QUALITY CONTROL RESULT (QC FLUID TTC1 LOT 0570 = 0.043 VS. EXPECTED RESULT = 0.089 MIU/L) DURING ROUTINE STABILITY TESTING RUN ON THE VITROS ECI SYSTEM. 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 PATIENT SAMPLES WERE TESTED AS PART OF THE STABILITY TRIAL. 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
    103188 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4020

    Patients

    Seq Age Sex Outcome Treatment
    1