BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 6101574 · Received November 15, 2016

    Report

    Report Number
    3007111389-2016-00216
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 15, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DURING A CORRELATION TESTING EVENT, HIGHER AND LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM TWENTY FOUR PATIENT SAMPLES PROCESSED ON A VITROS SYSTEM WHEN COMPARED TO A NON-VITROS METHOD (ROCHE COBAS) TO WHICH THE VITROS IPTH SHOULD HAVE A 1:1 CORRELATION. ORTHO HAS IDENTIFIED A 40% POSITIVE BIAS COMPARING VITROS IPTH TO ALTERNATIVE COMMERCIALLY AVAILABLE METHODS. THE ORIGIN OF THE OVERALL POSITIVE BIAS IS CURRENTLY NOT KNOWN. THE INVESTIGATION IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    HIGHER AND LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM TWENTY FOUR (24) PATIENT SAMPLES WHEN COMPARED TO A NON-VITROS METHOD (ROCHE COBAS) TO WHICH THE VITROS IPTH ASSAY SHOULD HAVE A 1:1 CORRELATION. (B)(6). 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 OBTAINED DURING A CORRELATION TEST EVENT AND WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755708 VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTIC CEW ORTHO-CLINICAL DIAGNOSTICS 0778

    Patients

    Seq Age Sex Outcome Treatment
    1