BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 14220640 · Received April 27, 2022

    Report

    Report Number
    3007111389-2022-00042
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 2, 2022
    Report Date
    April 27, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES DRAWN FROM ONE PATIENT USING A VITROS 5600 INTEGRATED SYSTEM AND A VITROS XT7600 INTEGRATED SYSTEM WHEN USING A VITROS IPTH REAGENT LOT 1520 WHEN COMPARED TO RESULTS OBTAINED FROM A NON-VITROS ROCHE SYSTEM. THE ASSIGNABLE CAUSE FOR THE HIGHER THAN EXPECTED VITROS IPTH RESULTS FOR THE PATIENT IS THE PRESENCE OF A SAMPLE INTERFERENT PRESENT IN THE PATIENT SAMPLES TESTED, IN THIS CASE, A HETEROPHILE. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS IPTH REAGENT PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (B)(6)

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES DRAWN FROM ONE PATIENT USING A VITROS 5600 INTEGRATED SYSTEM AND A VITROS XT7600 INTEGRATED SYSTEM WHEN USING A VITROS IPTH REAGENT LOT 1520 WHEN COMPARED TO RESULTS OBTAINED FROM A NON-VITROS ROCHE SYSTEM. PATIENT RESULTS OF 403.1, 415.1, 372.3 AND 372.5 PG/ML VERSUS EXPECTED RESULT OF 46.7 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 RESULTS WERE NOT REPORTED FROM THE LABORATORY AND 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
    1479745 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 1520

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown