BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH II REAGENT PACK

    MDR report key: 20988725 · Received December 20, 2024

    Report

    Report Number
    3007111389-2024-00236
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 19, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT A LOWER THAN EXPECTED VITROS INTACT PTH2 (IPTH2) RESULT WAS OBTAINED WHEN PROCESSING A PATIENT SAMPLE CORRELATION. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A VITROS INTACT PTH (IPTH) RESULT. THE VARIABILITY OBSERVED BETWEEN THE VITROS IPTH2 AND IPTH ASSAYS IS AN EXPECTED OUTCOME, GIVEN THE LACK OF STANDARDIZATION ACROSS IPTH MEASUREMENT METHODS. DIFFERENCES IN ASSAY DESIGN, ANTIBODY SELECTION, AND VARIOUS CIRCULATING FRAGMENTS CONTRIBUTE TO THE WELL-DOCUMENTED INTER-METHOD DISCREPANCIES IN PTH MEASUREMENT. ORTHO HAD PREVIOUSLY COMMUNICATED THAT THE VITROS IPTH ASSAY WAS APPROXIMATELY 20% HIGHER THAN A NON-VITROS ROCHE METHOD. THE VITROS IPTH2 ASSAY HAS ELIMINATED THAT 20% HIGH BIAS. THEREFORE, THERE IS AN EXPECTED 20% BIAS BETWEEN IPTH AND IPTH2 WHICH IS THE MOST LIKELY CAUSE OF THE EVENT. THERE IS NO INDICATION THE VITROS IPTH2 REAGENT IN USE AT THE TIME OF THE EVENT WAS NOT PERFORMING AS INTENDED AS VITROS QUALITY CONTROL FLUIDS PROCESSED FOR VITROS IPTH2 WERE PREDICTING AS EXPECTED AND NO ISSUES REGARDING ACCURACY OR PRECISION OF THE VITROS ASSAY WERE INDICATED BY THE CUSTOMER. HOWEVER, AS CONTROL RESULTS WERE NOT PROCESSED DURING THE TIMEFRAME OF THE EVENT, REAGENT PERFORMANCE CANNOT BE ENTIRELY CONFIRMED. ADDITIONALLY, PRECISION TESTING OF THE VITROS XT 7600 INTEGRATED SYSTEM WAS NOT PERFORMED, THEREFORE, NO ASSESSMENT OF THE INSTRUMENT'S PERFORMANCE AT THE TIME OF THE EVENT WAS MADE. HOWEVER, THE CUSTOMER GAVE NO INDICATION OF ANY VITROS XT 7600 SYSTEM MALFUNCTION, AND IT IS UNLIKELY AN INSTRUMENT PERFORMANCE ISSUE IS A CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS IPTH2 REAGENT LOT 0100.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS INTACT PTH2 (IPTH2) RESULT WAS OBTAINED WHEN PROCESSING A PATIENT SAMPLE CORRELATION. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A VITROS INTACT PTH (IPTH) RESULT. CORRELATION SAMPLE 2 VITROS IPTH2 RESULT OF 58.4 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 85.85 PG/ML (ABOVE THE REFERENCE INTERVAL) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CORRELATION PATIENT SAMPLE RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 608426.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152523 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH II REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS, INC. 0100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown