BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PTH (IPTH) ASSAY

    MDR report key: 2900409 · Received January 7, 2013

    Report

    Report Number
    1219913-2013-00008
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K020217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR IPTH RESULT IS UNKNOWN. A HETEROPHILIC INTERFERENT MAY HAVE CONTRIBUTED TO THE DISCORDANT RESULT. QUALITY CONTROLS ARE WITHIN RANGE. A SAMPLE HAS BEEN REQUESTED FOR FURTHER INVESTIGATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATIONS SECTION STATES THE FOLLOWING: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON (B)(4) 2013. 01/28/2013: ADDITIONAL INFORMATION: THE INITIAL MDR STATED THAT THE PATIENT SAMPLE WAS REQUESTED FOR FURTHER TESTING AT SIEMENS HEALTHCARE DIAGNOSTICS. THE PATIENT SAMPLE IS UNAVAILABLE AND NO ADDITIONAL TESTING CAN BE PERFORMED. THE CUSTOMER HAS DECLINED ANY FURTHER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A DISCORDANT HIGH ADVIA CENTAUR XP INTACT PTH (IPTH) TEST RESULT WAS OBTAINED BY THE CUSTOMER AND CONSIDERED DISCORDANT WHEN COMPARED TO THE DILUTION RESULTS AND HISTORICAL IPTH TEST RESULTS. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6179 ADVIA CENTAUR XP INTACT PTH (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 318

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR