BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS IPTH REAGENT

    MDR report key: 3881921 · Received June 18, 2014

    Report

    Report Number
    3007111389-2014-00127
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPEATABLE, FALSELY ELEVATED, VITROS IPTH RESULTS WERE PREDICTED FROM A SINGLE PATIENT SAMPLE AND A NON-OCD BIO-RAD CONTROL FLUID WHEN PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. AN UNKNOWN INSTRUMENT OR REAGENT ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS IPTH RESULTS FROM A PATIENT SAMPLE AND A NON-OCD BIO-RAD CONTROL FLUID PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. CONTROL FLUID VITROS IPTH RESULT: 825 PG/ML VS EXPECTED 629 PG/ML. PATIENT SAMPLE VITROS IPTH RESULT: 74 AND 71 PG/ML VS EXPECTED 33 PG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS IPTH PATIENT RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357559 VITROS IMMUNODIAGNOSTICS PRODUCTS IPTH REAGENT IN-VITRO DIAGNOSTIC CEW ORTHO-CLINICAL DIAGNOSTICS 0480

    Patients

    Seq Age Sex Outcome Treatment
    1