BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCT INTACT PTH REAGENT PACK

    MDR report key: 6028276 · Received October 13, 2016

    Report

    Report Number
    3007111389-2016-00191
    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 (B)(6) OFFICE WAS NOTIFIED OF THIS ISSUE ON (B)(6) 2016. REFER TO REPORT NUMBER (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. SAMPLE 009: 55.5 PG/ML VERSUS EXPECTED RESULT OF 38.9 PG/ML; SAMPLE 024: 59.7 PG/ML VERSUS EXPECTED RESULT OF 36.5 PG/ML; SAMPLE 031: 44.9, 39.4, 40.4 AND 40.6 PG/ML VERSUS EXPECTED RESULT OF 23.1 PG/ML; SAMPLE 048: 79.4, 94.0, 70.7, 100.3, 73.7 AND 79.1 PG/ML VERSUS EXPECTED RESULT OF 46.9 PG/ML; SAMPLE 058: 72.3 PG/ML VERSUS EXPECTED RESULT OF 52.0 PG/ML; SAMPLE 063: 66.4 PG/ML VERSUS EXPECTED RESULT OF 48.6 PG/ML; SAMPLE 068: 80.5 PG/ML VERSUS EXPECTED RESULT OF 58.5 PG/ML; SAMPLE 070: 96.5 AND 92.4 PG/ML VERSUS EXPECTED RESULT OF 68.7 PG/ML; SAMPLE 084: 35.0 PG/ML VERSUS EXPECTED RESULT OF 18.5 PG/ML; SAMPLE 098: 87.1 PG/ML VERSUS EXPECTED RESULT OF 66.5 PG/ML; SAMPLE 102: 70.2 PG/ML VERSUS EXPECTED RESULT OF 52.8 PG/ML; SAMPLE 104: 68.5 PG/ML VERSUS EXPECTED RESULT OF 50.6 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 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 FIVE 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
    677012 VITROS IMMUNODIAGNOSTIC PRODUCT INTACT PTH REAGENT PACK IN VITRO DIAGNOSTIC CEW ORTHO-CLINICAL DIAGNOSTICS 0710

    Patients

    Seq Age Sex Outcome Treatment
    1