BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1880001 · Received October 19, 2010

    Report

    Report Number
    2432235-2010-00142
    Event Type
    Other
    Date Received
    October 19, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 4, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MOI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER SITE. THE CUSTOMER RERAN THE SAMPLE ISSUED THE CORRECTED RESULT TO THE PHYSICIAN. THIS EVENT IS AN ISOLATED INCIDENT. THE CASE TO THE (B)(4) DISCORDANT RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR HBCT RESULT WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. UPON RETEST THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER MOI SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1