BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH (IPTH) REAGENT

    MDR report key: 2222082 · Received August 24, 2011

    Report

    Report Number
    3007111389-2011-00117
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT REPEATABLE BUT DISCREPANT VITROS IPTH RESULTS WERE OBTAINED FROM A PATIENT SAMPLE PROCESSED ON TWO DIFFERENT VITROS 5600 SYSTEMS COMPARED TO THE RESULT OBTAINED USING AN ALTERNATE NON VITROS IPTH METHOD. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THERE WAS NO EVIDENCE TO SUGGEST A REAGENT OR INSTRUMENT MALFUNCTION HAD OCCURRED. METHOD TO METHOD VARIATION BETWEEN THE VITROS IPTH AND THE ALTERNATE NON VITROS IPTH METHODS CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED VITROS IPTH RESULTS FROM A PATIENT SAMPLE PROCESSED ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS THAT WERE DISCREPANT FROM THE RESULT OBTAINED USING AN ALTERNATE NON VITROS IPTH METHOD. REPEATABLE VITROS IPTH RESULTS OF 59.9 AND 58.4 PG/ML VS. AN IPTH RESULT OF 42 PG/ML USING AN ALTERNATE NON VITROS IPTH METHOD WERE OBTAINED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCREPANT VITROS IPTH PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. 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
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH (IPTH) REAGENT IN VITRO DIAGNOSTIC CEW ORTHO-CLINICAL DIAGNOSTICS 0120

    Patients

    Seq Age Sex Outcome Treatment
    1