BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    MDR report key: 2062864 · Received April 19, 2011

    Report

    Report Number
    1219913-2011-00048
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K020217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTING A LOW DISCORDANT IPTH TEST RESULT OF 13. THE CUSTOMER STATES THAT THE QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE LIMITS AND THERE ARE NO REPORTED IPTH RESULTS OF 13 ON EITHER ADVIA CENTAUR SYSTEMS. USER ERROR IS SUSPECTED AND MOST LIKELY THE CONTRIBUTING CAUSE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN UNCONFIRMED DISCORDANT LOW IPTH RESULT WAS REPORTED BY THE CUSTOMER ON A PATIENT THAT WAS UNDERGOING A PARATHYROIDECTOMY. THE CUSTOMER QUESTIONED THE LOW RESULT WHEN COMPARED TO THE INITIAL TEST RESULT RUN ON THE FIRST ADVIA CENTAUR AND FOLLOW UP TEST RESULTS RUN ON THE SECOND ADVIA CENTAUR SYSTEM. DUE TO THE ERRONEOUS RESULT REPORTED BY THE CUSTOMER INITIALLY, THE PATIENT WAS RETURNED TO SURGERY. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH RESULT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR INTACT PTH (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 171

    Patients

    Seq Age Sex Outcome Treatment
    1