BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP VANCOMYCIN (VANC) ASSAY

    MDR report key: 6352576 · Received February 23, 2017

    Report

    Report Number
    1219913-2017-00031
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Date of Event
    January 25, 2017
    Report Date
    April 13, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LEH
    PMA / PMN Number
    K951059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUALITY CONTROL VALUES WERE ACCEPTABLE. THERE WERE NO ERROR MESSAGES AT THE TIME OF THE EVENT. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP VANCOMYCIN (VANC) 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00031 ON FEBRUARY 23, 2017. ON 04/05/2017 ADDITIONAL INFORMATION: SIEMENS DOES NOT HAVE ANY INFORMATION REGARDING THE LIST OF COMPOUNDS THAT WERE ADMINISTERED TO THE PATIENT OTHER THAN HEPARIN AND DOES NOT KNOW HOW THEY WOULD IMPACT THE PATIENT RESULTS. THE METHOD THE SAMPLE WAS DRAWN APPEARS TO BE SUSPICIOUS OF THE RESIDUAL VANCOMYCIN IN THE BLOOD DRAW AT THIS TIME. THIS APPEARS TO BE A PREANALYTICAL ISSUE - INCORRECT SAMPLE COLLECTION PROCEDURE. SIEMENS DOES NOT BELIEVE TESTING OF THE SAMPLE WOULD BE NECESSARY GIVEN THE AGE OF THE PATIENT. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP VANCOMYCIN (VANC) RESULTS IS UNKNOWN. POSSIBLE PREANALYTICAL ISSUE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT HIGH ADVIA CENTAUR XP VANCOMYCIN RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT WAS TESTED FOR VANCOMYCIN ON (B)(6) AND THE RESULT WAS LOWER. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN. FOR THE INITIAL VANCOMYCIN TESTING, THE BLOOD SAMPLE WAS DRAWN FROM THE SAME INDWELLING CATHETER AS THE VANCOMYCIN INJECTION. THE VALUE WAS HIGHER THAN EXPECTED. THE SAMPLE WAS STORED AT -40 DEGREES AND RETESTED ON FEBRUARY 2ND. THE RESULT WAS STILL HIGH. THE COLLECTED BLOOD VOLUME WAS 2 ML AND SEKISUI "INCEPACK" II-D 7 ML TUBE WAS USED FOR COLLECTION. THE VANCOMYCIN MEDICINE ADMINISTRATION WAS DISCONTINUED BECAUSE THE RESULT WAS HIGHER THAN EXPECTED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VANCOMYCIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135745 ADVIA CENTAUR XP VANCOMYCIN (VANC) ASSAY VANCOMYCIN IMMUNOASSAY LEH SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 017204

    Patients

    Seq Age Sex Outcome Treatment
    1 76 DA