BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR RUBELLA G (RUB G) ASSAY

    MDR report key: 3021212 · Received March 26, 2013

    Report

    Report Number
    1219913-2013-00073
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LFX
    PMA / PMN Number
    K003412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA, REPLACED PARTS, AND DID NOT FIND AN INSTRUMENT MALFUNCTION. THE FSE RAN TWENTY REPLICATES OF QUALITY CONTROLS, WHICH WERE WITHIN RANGE. ON A SUBSEQUENT VISIT BY THE FSE, THE FOLLOWING WERE CHECKED AND NO ISSUES WERE IDENTIFIED: SAMPLE PROBE BOTTOM CALIBRATION; SAMPLE PROBE SPINDEL; SAMPLE PROBE RETROFITTING; INCUBATION RING; RING MOTION. THE CUSTOMER REPORTED THAT THEY HAD OBTAINED ADDITIONAL DISCORDANT RESULTS AFTER THE INITIAL FSE SERVICE VISITS. AN FSE WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE READJUSTED THE SAMPLE PROBE CUVETTE BOTTOM POSITION, REPLACED THE SAMPLE AIR PUMP ASSEMBLY, AND REPLACED THE PRINTED CIRCUIT BOARD SAMPLE PRESSURE SENSOR. THE FSE CALIBRATED THE INSTRUMENT, RAN QUALITY CONTROLS, AND RAN PRECISION, ALL OF WHICH WAS WITHIN RANGE. AN ADDITIONAL DISCORDANT RESULT WAS OBTAINED AFTER THE SERVICE VISIT FOR ANOTHER ASSAY. THE DECISION WAS MADE TO REPLACE THE ADVIA CENTAUR S/N (B)(4). THE INSTRUMENT WAS REPLACED ON (B)(4) 2013. INSTRUMENT INFORMATION: BRAND NAME: ADVIA CENTAUR; COMMON DEVICE NAME: IMMUNOASSAY ANALYZER; MODEL #: ADVIA CENTAUR; CATALOG #: 078-A002-02; PRODUCT CODE: JJE; THE 510(K): K971418.

    Description of Event or Problem · 1

    A (B)(4) ADVIA CENTAUR RUBELLA G RESULT WAS OBTAINED FOR A PATIENT SAMPLE. REPEAT TESTING WAS PERFORMED AFTER CENTRIFUGATION AND THE RESULT WAS POSITIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123575 ADVIA CENTAUR RUBELLA G (RUB G) ASSAY RUBELLA G IMMUNOASSAY LFX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 170

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR