BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 3356002 · Received September 18, 2013

    Report

    Report Number
    1219913-2013-00216
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Date of Event
    August 5, 2013
    Report Date
    September 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    PMA / PMN Number
    K012183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE PERFORMED CHECKS, VERIFICATIONS AND CLEANING ON THE SYSTEM. THE FSE FOUND THAT THE PINCH VALVE FOR ASPIRATION 2 WAS MISPOSITIONING AND REPAIRED. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN AND MAY BE ATTRIBUTED TO TO SYSTEM MALFUNCTION. NO PATIENT SAMPLE IS AVAILABLE FOR FURTHER TESTING. THE QUALITY CONTROL AND CALIBRATION WERE ACCEPTABLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. INSTRUMENT INFORMATION: BRAND NAME: ADVIA CENTAUR XP; COMMON DEVICE NAME: IMMUNOASSAY ANALYZER; MODEL #: ADVIA CENTAUR XP; CATALOG #: 078-A002-XX; PRODUCT CODE: JJE; 510(K): K041133; SERIAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. REPEAT TESTING WAS PERFORMED ON THE SAME PATIENT SAMPLE AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS TESTED WITH THE ADVIA CENTAUR XP TOXO M AND THE RESULT WAS NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXOPLASMA G RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469489 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 061191

    Patients

    Seq Age Sex Outcome Treatment
    1