BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15194257 · Received August 9, 2022

    Report

    Report Number
    3007111389-2022-00077
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 9, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING A VITROS XT7600 INTEGRATED SYSTEM AND VITROS IPTH REAGENT LOT 1560 WHEN COMPARED TO RESULTS OBTAINED FROM A NON-VITROS ROCHE AND SIEMENS SYSTEM. THE ASSIGNABLE CAUSE FOR THE HIGHER THAN EXPECTED VITROS IPTH RESULTS FOR THE PATIENT SAMPLE IS THE PRESENCE OF A SAMPLE INTERFERENT IN THE PATIENT SAMPLE TESTED, IN THIS CASE, HETEROPHILIC INTERFERENCE. BASED ON ACCEPTABLE HISTORICAL QUALITY CONTROL RESULTS, A VITROS IPTH REAGENT PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS IPTH LOT 1560. EMAIL ADDRESS FOR CONTACT OFFICE (B)(6).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING A VITROS XT7600 INTEGRATED SYSTEM AND VITROS IPTH REAGENT LOT 1560 WHEN COMPARED TO RESULTS OBTAINED FROM A NON-VITROS ROCHE SYSTEM. PATIENT SAMPLE 1 RESULTS OF 726.0 AND 709.0 PG/ML VERSUS EXPECTED ROCHE RESULT OF 13.0 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS IPTH RESULT OF 726.0 PG/ML WAS REPORTED FROM THE LABORATORY. THE ROCHE IPTH RESULT OF 13.0 PG/ML WAS LATER REPORTED FOR THE PATIENT BUT NO CORRECTED REPORT ISSUED. NO TREATMENT WAS STOPPED/STARTED/ALTERED BASED ON THE HIGHER THAN EXPECTED RESULT. ORTHO IS NOT AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295958 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 1560

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown