BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAY

    MDR report key: 7436765 · Received April 17, 2018

    Report

    Report Number
    1219913-2018-00130
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    January 15, 2018
    Report Date
    April 17, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MKW
    UDI-DI
    00630414524450
    PMA / PMN Number
    K071455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CYCLOSPORINE (CSA) RESULTS IS UNKNOWN. SIEMENS REVIEWED THE CUSTOMER DATA. THE OVERALL BIAS IS IN LINE WITH WHAT IS EXPECTED IN THE ADVIA CENTAUR CYCLOSPORINE IFU (INSTRUCTIONS FOR USE), 10629836_EN REV, K, 2017-12 ACCURACY/METHOD COMPARISON SECTION WITH TANDEM-MS. IN ADDITION THE ADVIA CENTAUR CYCLOSPORINE ASSAY DOES NOT HAVE A CLAIM TO BE COMPARABLE TO ANY OTHER METHODS OR PLATFORMS. THE LC/MS/MS METHODS ALSO DO NOT SEEM TO BE IN ALIGNMENT WITH EACH OTHER AND DEMONSTRATE VARIABILITY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE IFU STATES IN THE LIMITATIONS SECTION: "ALWAYS USE MEASUREMENTS OF CSA IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION."

    Description of Event or Problem · 1

    A HIGH ADVIA CENTAUR XP CYCLOSPORINE (CSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE DURING A METHOD COMPARISON. THE CYCLOSPORINE RESULTS WERE HIGHER THAN THE LC-MS/MS METHODS. THE PATIENT SAMPLE WAS TESTED ON THE LC-MS/MS AT TWO LABORATORIES. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY ONE PHYSICIAN. CORRECTED RESULTS WERE REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYCLOSPORINE (CSA) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278638 ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAY CYCLOSPORINE ASSAY MKW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 77934031 00630414524450

    Patients

    Seq Age Sex Outcome Treatment
    1