BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS IPTH REAGENT

    MDR report key: 2088916 · Received May 13, 2011

    Report

    Report Number
    3007111389-2011-00058
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT SERUM AND PLASMA VITROS IPTH RESULTS WERE OBTAINED FROM A SINGLE PATIENT DURING A PATIENT SAMPLE CORRELATION STUDY. NO MALFUNCTION OF THE VITROS IPTH REAGENT OR VITROS ANALYZERS WAS IDENTIFIED AS A CONTRIBUTING FACTOR. SAMPLE INTEGRITY CANNOT BE RULED OUT AS CONTRIBUTING FACTORS AS THE EXACT HISTORY OF THE SAMPLES IS UNKNOWN. AN ASSIGNABLE CAUSE OF THE BIASED RESULTS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A PATIENT SAMPLE CORRELATION STUDY PERFORMED TO COMPARE VITROS IPTH RESULTS OBTAINED AT THE CUSTOMER'S SITE TO VITROS IPTH RESULTS OBTAINED AT A DIFFERENT LOCATION, DISCORDANT SERUM AND PLASMA RESULTS WERE OBTAINED FROM A SINGLE PATIENT. THE FOLLOWING DISCORDANT SERUM (S) AND PLASMA (P) VITROS IPTH RESULTS WERE OBTAINED (UNIT IS PG/ML): 109.6 (S) VS. 81.1 (P), 115.9 (S) VS. 81.1 (P) AND 81.1 (P) VS. 115.9 (S). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT VITROS IPTH RESULTS WERE NOT REPORTED OUT OF THE CUSTOMER'S LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS IPTH REAGENT IN-VITRO DIAGNOSTIC CEW ORTHO-CLINICAL DIAGNOSTICS 0060

    Patients

    Seq Age Sex Outcome Treatment
    1