BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 10491030 · Received September 3, 2020

    Report

    Report Number
    3007111389-2020-00118
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 3, 2020
    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 A HIGHER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED FROM A PATIENT SAMPLE DURING A PATIENT CORRELATION WHICH WAS PROCESSED AS PART OF TROUBLESHOOTING USING VITROS TSH REAGENT LOT 6180 ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED PATIENT SAMPLE RESULT IS AN ISSUE RELATED TO PRE-ANALYTICAL SAMPLE HANDLING. IT WAS CONFIRMED THAT SEVERAL OF THE PATIENT SAMPLES PROCESSED INCLUDING PATIENT SAMPLE 9 WERE NOT RE-CENTRIFUGED BEFORE BEING RE-PROCESSED USING VITROS TSH LOT 6180 AND THE SERUM WAS LIKELY NOT SEPARATED FROM THE CELLULAR MATERIAL. HOWEVER, AN ISSUE RELATED TO PRE-ANALYTICAL HANDLING COULD NOT BE ENTIRELY CONFIRMED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS TSH REAGENT LOTS 6180.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT OBTAINED FROM VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT ON A VITROS 5600 INTEGRATED SYSTEMS. PATIENT SAMPLE 9 VITROS TSH RESULT OF 3.08* MIU/L VS THE EXPECTED RESULT OF 1.83 MIU/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS TSH RESULTS WAS NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951121 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS 6180

    Patients

    Seq Age Sex Outcome Treatment
    1