BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15414152 · Received September 13, 2022

    Report

    Report Number
    3007111389-2022-00085
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 15, 2022
    Report Date
    September 13, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS OBTAINED WHEN TESTED USING A NON-VITROS THERMOFISHER OMNI-IMMUNE QUALITY CONTROL (QC) FLUID ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE MOST LIKELY ASSIGNABLE CAUSE FOR THE HIGHER THAN EXPECTED, INTACT PTH (IPTH) RESULT IS AN ISSUE ISOLATED TO THE PREPARATION OF THE QC FLUIDS. THERE IS NO INDICATION THAT THE VITROS ECI INTEGRATED SYSTEM OR THE VITROS IPTH REAGENT MALFUNCTIONED IN ANY WAY. (B)(4).

    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 OBTAINED WHEN TESTED USING A NON-VITROS THERMOFISHER OMNI-IMMUNE QUALITY CONTROL (QC) FLUID ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. (B)(6). 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 IPTH RESULTS WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969901 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 1550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown