BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 18940874 · Received March 20, 2024

    Report

    Report Number
    3007111389-2024-00057
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 19, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    10758750000227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A DISCORDANT, LOWER THAN EXPECTED TSH RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS TSH LOT 7211 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS LOWER WHEN COMPARED TO A NON-VITROS ROCHE TSH RESULT FROM ALTERNAT SAMPLE FOR THE PATIENT. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. A VITROS TSH LOT 7211 REAGENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS UNACCEPTABLE ACCURACY AND PRECISION WAS OBSERVED FOLLOWING A REVIEW OF THE BIORAD QC RESULTS LEADING UP TO THE EVENT. HOWEVER, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS TSH REAGENT LOT 7211. THERE WAS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION, HOWEVER, AS NO DIAGNOSTIC PRECISION TESTING WAS CONDUCTED AROUND THE TIME OF THE EVENT, AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS IT WAS NOT POSSIBLE TO DETERMINE WHETHER THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE'S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. PATIENT SAMPLE MIX UP CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS DISCORDANT RESULTS WERE OBTAINED FOR THE PATIENT SAMPLES COLLECTED FOUR DAYS APART AND DISCORDANCE WAS ALSO OBSERVED BETWEEN VITROS E2 AND ROCHE E2 TESTING. THE DISCORDANCE OBSERVED FOR TSH AND E2 TESTING WAS CONSISTENT WITH BIOTIN INTERFERENCE, HOWEVER, PATIENT 1 WAS NOT IN RECEIPT OF A BIOTIN SUPPLEMENT. THEREFORE, BIOTIN INTERFERENCE DID NOT CONTRIBUTE TO THE DISCORDANCE OBSERVED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, LOWER THAN EXPECTED TSH RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS TSH LOT 7211 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS LOWER WHEN COMPARED TO A NON-VITROS ROCHE TSH RESULT FROM ALTERNAT SAMPLE FOR THE PATIENT. PATIENT 1 SAMPLE 1, VITROS TSH RESULT OF 0.03 MIU/L (HYPERTHYROID) VERSUS A PATIENT 1 SAMPLE 2 ROCHE RESULT OF 1.93 MIU/L (EUTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, LOWER THAN EXPECTED VITROS TSH RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527681 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7211 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown