BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TSH3-ULTRA (TSH3-UL)

    MDR report key: 3781357 · Received April 30, 2014

    Report

    Report Number
    1219913-2014-00120
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLW
    PMA / PMN Number
    K083844
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS' CUSTOMER SERVICE ENGINEER (CSE) WENT ON SITE FOR SYSTEM INSPECTION. THE CSE FOUND PUDDLING UNDER PORT THREE OF THE ASPIRATE WASH MANIFOLD. THE WASH MANIFOLD WAS REPLACED. THE REAGENT PROBES WERE CALIBRATED. THE CSE CLEANED AROUND ALL PORTS AT THE INCUBATION RING. THESE WERE DIRTY. IT WAS OBSERVED THAT THE CUSTOMER WAS NOT PERFORMING PROPER MAINTENANCE ON THE UNIT SINCE (B)(6). NO OTHER ISSUES WERE IDENTIFIED. NO CONCLUSION CAN BE DRAWN. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR TSH3-ULTRA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. INSTRUMENT INFORMATION: BRAND NAME: ADVIA CENTAUR: COMMON DEVICE NAME: IMMUNOASSAY ANALYZER, MODEL #: ADVIA CENTAUR, SERIAL NUMBER (B)(4), 510(K): K041133.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR TSH3-ULTRA RESULTS WERE OBTAINED FOR SAMPLES FROM THE SAME PATIENT. THE FIRST RESULT WAS DISCORDANT WITH THE SECOND SAMPLE RESULT WHICH WAS HIGHER. THE SECOND SAMPLE WAS TESTED ON A DIFFERENT DAY. REPEAT TESTING WAS PERFORMED ON THE SECOND SAMPLE. THERE WAS NOT ENOUGH SAMPLE VOLUME TO CONFIRM THE RESULT OF THE FIRST SAMPLE. THE PHYSICIAN QUESTIONED THE RESULTS. IT IS UNKNOWN WHICH IS THE EXPECTED RESULT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258801 ADVIA CENTAUR TSH3-ULTRA (TSH3-UL) TSH3-UL IMMUNOASSAY JLW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 272

    Patients

    Seq Age Sex Outcome Treatment
    1