BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCT INTACT PTH REAGENT PACK

    MDR report key: 6028241 · Received October 13, 2016

    Report

    Report Number
    3007111389-2016-00188
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    October 13, 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 INTERNAL TESTING, HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM TWELVE PATIENT SAMPLES PROCESSED WHEN COMPARED TO A NON-VITROS METHOD (ROCHE) TO WHICH THE VITROS IPTH SHOULD HAVE A 1:1 CORRELATION. ORTHO HAS IDENTIFIED A 40% POSITIVE BIAS COMPARING VITROS IPTH TO ROCHE ACROSS ALL SAMPLES IN THE CORRELATION STUDY. THE ORIGIN OF THE POSITIVE BIAS IS CURRENTLY NOT KNOWN. THE INVESTIGATION IS ONGOING. THE FDA (B)(4) WAS NOTIFIED OF THIS ISSUE ON 13 OCTOBER 2016. REFER TO REPORT NUMBER 3007111389-10/13/2016-001-C. (B)(4).

    Description of Event or Problem · 1

    DURING INTERNAL TESTING, AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) PRINCIPLE SCIENTIST OBTAINED HIGHER THAN EXPECTED VITROS IPTH RESULTS ON TWELVE PATIENT SAMPLES COMPARED TO A NON-VITROS METHOD (ROCHE) TO WHICH THE VITROS IPTH 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 INTERNAL TESTING AND WERE NOT REPORTED TO PHYSICIANS. THERE WERE NO ALLEGATION OF PATIENT HARM AS A RESULT OF THESE EVENTS. THIS REPORT IS NUMBER TWO OF SEVEN MDR'S FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679132 VITROS IMMUNODIAGNOSTIC PRODUCT INTACT PTH REAGENT PACK IN VITRO DIAGNOSTIC CEW ORTHO-CLINICAL DIAGNOSTICS 0738

    Patients

    Seq Age Sex Outcome Treatment
    1