BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 2921125 · Received January 17, 2013

    Report

    Report Number
    3007111389-2013-00014
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    October 19, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TSH QUALITY CONTROL RESULT WHILE USING THE VITROS 5600 SYSTEM. ROOT CAUSE FOR THE HIGHER THAN EXPECTED RESULTS COULD NOT BE DETERMINED, HOWEVER, THE POSSIBILITY THAT POOR SAMPLE HANDLING OR AN UNEXPECTED REAGENT PERFORMANCE HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TSH QUALITY CONTROL RESULT (BIORAD LOT 40771= 1.643 VS. EXPECTED RESULT=0.638 MIU/L ) WHILE USING THE VITROS 5600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT 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
    26078 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4070

    Patients

    Seq Age Sex Outcome Treatment
    1