BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOTAL HCG (THCG)

    MDR report key: 6085321 · Received November 8, 2016

    Report

    Report Number
    1219913-2016-00210
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 24, 2016
    Report Date
    December 7, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JHI
    PMA / PMN Number
    K925277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TOTAL HCG RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "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: "IF AN ABERRANT OR ABNORMAL RESULT, AS DEFINED BY THE LABORATORY PROTOCOL, OCCURS, LABORATORY PERSONNEL SHOULD FIRST MAKE CERTAIN THAT THE SYSTEM IS PERFORMING AND IS OPERATED AND MAINTAINED IN ACCORDANCE WITH THE PRODUCT LABELING. THE USER SHOULD THEN FOLLOW THE LABORATORY PROTOCOL FOR ADVISING THE CLINICIAN OF A RESULT THAT APPEARS TO HAVE DEVIATED FROM THE NORMS ESTABLISHED BY THE LABORATORY."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00210 ON NOVEMBER 8, 2016. ON 11/03/2016 ADDITIONAL INFORMATION: A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE PERFORMED A TOTAL SERVICE CALL. THE FSE VERIFIED THE FUNCTION OF THE ASPIRATE WASH AREA; CHECKED PROBE CALIBRATIONS; AND CHECKED BACKGROUND COUNT READINGS AS WELL AS WET WATER AND DRY. THE CUSTOMER RAN THE MASTER CURVE MATERIAL (MCM) AND THE RESULTS WERE ACCEPTABLE. NO ISSUES WERE IDENTIFIED. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00210 ON NOVEMBER 8, 2016. SIEMENS FILED THE MDR 1219913-2016-00210 SUPPLEMENTAL REPORT 1 ON NOVEMBER 15, 2016. ON 12/03/2016 ADDITIONAL INFORMATION: THE TECHNICAL APPLICATION SPECIALIST (TAS) WENT TO THE CUSTOMER SITE AND PERFORMED A DILUTION PROTOCOL WITH FOUR SAMPLES. (B)(6). THE DILUTION PROTOCOL WAS SATISFACTORY. THE CUSTOMER INDICATED NO FURTHER DILUTION ISSUES POST TOTAL SERVICE CALL. THE FSE DID NOT IDENTIFY ANY ISSUES. THE CAUSE FOR THE DISCORDANT TOTAL HCG RESULTS IS UNKNOWN. THE MANUAL DILUTIONS ARE SUSPECTED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP TOTAL HCG PATIENT RESULTS WERE OBTAINED FOR SAMPLES FROM THE SAME PATIENT. THE RESULTS WERE DISCORDANT BETWEEN AUTO-DILUTION AND MANUAL DILUTION. ONE OF THE SAMPLES WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS HIGHER. THE PHYSICIAN HAS NOT QUESTIONED ANY OF THE RESULTS THAT WERE REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737291 ADVIA CENTAUR XP TOTAL HCG (THCG) TOTAL HCG JHI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 279

    Patients

    Seq Age Sex Outcome Treatment
    1