BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS IPTH REAGENT

    MDR report key: 2080331 · Received May 6, 2011

    Report

    Report Number
    3007111389-2011-00047
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 6, 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 A HIGHER THAN EXPECTED VITROS IPTH RESULT WAS OBTAINED DURING A PATIENT CORRELATION STUDY PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO AN OEM ANALYZER. IN ADDITION, TWO HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED WHEN COMPARING SERUM AND PLASMA TYPE SAMPLES PROCESSED ON THE VITROS 5600 SYSTEM. NO IPTH REAGENT OR VITROS 5600 INSTRUMENT RELATED MALFUNCTIONS WERE OBSERVED AT THE TIME OF THE EVENT. SAMPLE HANDLING AND STORAGE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. AS STATED IN THE VITROS IPTH IFU, "SPECIMEN TYPES SHOULD NOT BE USED INTERCHANGEABLY DURING THE SERIAL MONITORING OF AN INDIVIDUAL PATIENT AS MEASURED CONCENTRATIONS MAY VARY SLIGHTLY BETWEEN SAMPLE TYPES." THE MAGNITUDE OF THE OBSERVED DIFFERENCE BETWEEN THE SERUM AND CORRESPONDING PLASMA VITROS IPTH RESULTS IS UNEXPECTED. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS IPTH RESULT (199.9 PG/ML) DURING A PATIENT CORRELATION STUDY PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO AN OEM ANALYZER. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULT WAS NOT REPORTED OUT OF THE LABORATORY BECAUSE TESTING PERFORMED WAS FOR THE CORRELATION STUDY ONLY. THE OEM ANALYZER PATIENT RESULT WAS 145.0 PG/ML. IN ADDITION, TWO HIGHER THAN EXPECTED VITROS IPTH RESULTS (SERUM SAMPLE 1 = 1145 PG/ML, SERUM SAMPLE 2 = 96.6 PG/ML) WERE OBTAINED WHEN COMPARING SERUM AND PLASMA TYPE SAMPLES (PLASMA SAMPLE 1 = 868.5 PG/ML, PLASMA SAMPLE 2 = 72.8 PG/ML) PROCESSED ON THE VITROS 5600 SYSTEM. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBER (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 0071

    Patients

    Seq Age Sex Outcome Treatment
    1