BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TESTOSTERONE (TSTO)

    MDR report key: 3241395 · Received July 22, 2013

    Report

    Report Number
    1219913-2013-00161
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CDZ
    PMA / PMN Number
    K934562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON JULY 22, 2013. 09/25/2013 ADDITIONAL INFORMATION: THE CUSTOMER SENT EIGHT PATIENT SAMPLES THAT WERE CONSIDERED CLINICALLY DISCORDANT TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. THE SAMPLES WERE TESTED ON THE ADVIA CENTAUR PLATFORM AND THE LCMS/MS TESTING. TESTOSTERONE RESULTS (NG/DL): SHARP REES PATIENT ID: (B)(6), LCMS/MS CUSTOMER RESULTS % BIAS VS LCMS/MS NG/DL: 902, CENTAUR: 756, ALTERNATE METHOD: 1123, CENTAUR: -16%, ALTERNATE METHOD: 25%; (B)(6), 747, 1034, 1330, 38%, 78%, (B)(6), 481, 187, 407, -61%, -15%, (B)(6), 754, 643, 868, -15%, 15%, (B)(6), 305, 291, 406, -5%, 33%, (B)(6), 343, 217, 368, -37%, 7%, (B)(6), 325, 233, 343, -28%, 6%, (B)(6), 754, 690, 825, -8%, 9%. SIEMENS RESULTS: PATIENT ID: (B)(6), LCMS/MS: 902, CENTAUR: 962.46, %BIAS VS LCMS/MS: 7%; (B)(6), 747, 1003.41, 34%, (B)(6), 481, 567.14, 18%, (B)(6), 754, 802.57, 6%, (B)(6), 305, 488.81, 60%, (B)(6), 343, 321.27, -6%, (B)(6), 325, 294.09, -10%, (B)(6), 754, 728.59, -3%. SIEMENS OBTAINED HIGHER RESULTS FOR 7 OF THE 8 SAMPLES RUN WITH THE ADVIA CENTAUR TESTOSTERONE ASSAY THAN THE CUSTOMER. THE RESULTS OBTAINED BY SIEMENS FOR THE SAMPLES WERE COMPARABLE TO THE LCMS/MS RESULTS. FOR ALL SAMPLES EXCEPT ONE, THE ADVIA CENTAUR TESTOSTERONE RESULTS OBTAINED BY THE CUSTOMER WERE LOWER THAN THE LCMS/MS RESULTS. FOR ALL SAMPLES EXCEPT ONE, THE ALTERNATE METHOD RESULTS WERE HIGHER THAN THE LCMS/MS RESULTS. THE CUSTOMER RAN THE SAMPLES IN SINGLET WITH ADVIA CENTAUR TESTOSTERONE ASSAY AND THE ALTERNATE METHOD TESTOSTERONE ASSAY. THE CUSTOMERS SAMPLES THAT WERE TESTED WERE PART OF A SUBSET OF 15 SAMPLES CITED OUT OF A 457 PATIENT METHOD COMPARISON THAT THE CUSTOMER QUESTIONED AS RESULTING TOO LOW WITH THE ADVIA CENTAUR TESTOSTERONE ASSAY AND AS BEING CLINICALLY DISCORDANT. THE CUSTOMERS DATA AND THE SIEMENS DATA COLLECTIVELY SUGGEST THAT THE LOW ADVIA CENTAUR TESTOSTERONE RESULTS OBTAINED BY THE CUSTOMER FOR THESE SAMPLES IS LIKELY DUE TO THE NATURAL EXPECTED VARIATION IN MEASUREMENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TESTOSTERONE RESULTS IN COMPARISON TO THE ALTERNATE METHOD IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    LOW ADVIA CENTAUR XP TESTOSTERONE RESULTS WERE OBTAINED ON SAMPLES FROM SEVERAL PATIENTS. THE LOW RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO AN ALTERNATE METHOD. REPEAT TESTING WAS NOT PERFORMED. THE PATIENT SAMPLES WERE TESTED AS PART OF A METHOD COMPARISON. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TESTOSTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340513 ADVIA CENTAUR XP TESTOSTERONE (TSTO) TESTOSTERONE IMMUNOASSAY CDZ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1