BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCT TSH REAGENT PACK

    MDR report key: 6082849 · Received November 7, 2016

    Report

    Report Number
    3007111389-2016-00208
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 4, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING 2 LOTS OF VITROS TSH REAGENT. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. HOWEVER, AN UNKNOWN SAMPLE SPECIFIC INTERFERENT OR THE VITROS ANALYZERS IN USE COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT IS UNKNOWN IF THE CUSTOMER IS ADHERING TO THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDATIONS FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. BASED ON HISTORICAL VITROS TSH REAGENT LOT 5148 QUALITY CONTROL RESULTS, THERE IS NO INDICATION A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED TSH RESULTS FROM A SINGLE PATIENT SAMPLE USING VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND A VITROS 5600 INTEGRATED SYSTEM. VITROS TSH REAGENT LOT 5148 WITH VITROS 3600: PATIENT SAMPLE 1: VITROS TSH OF 0.28 MIU/L VS. TSH RESULT OF 4.66 AND 5.39MIU/L FROM TWO NON ORTHO TSH METHODS. VITROS TSH REAGENT LOT 5248 WITH VITROS 5600: PATIENT SAMPLE 1: VITROS TSH OF 0.406 MIU/L VS. TSH RESULT OF 4.66 AND 5.39MIU/L FROM TWO NON ORTHO TSH METHODS. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY, AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE AFFECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734404 VITROS IMMUNODIAGNOSTICS PRODUCT TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 5148

    Patients

    Seq Age Sex Outcome Treatment
    1