BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVIA CENTAUR

    MDR report key: 839086 · Received April 12, 2007

    Report

    Report Number
    MW1042577
    Event Type
    Injury
    Date Received
    April 12, 2007
    Date of Event
    February 22, 2007
    Report Date
    April 3, 2007
    Manufacturer
    SIEMENS CORP.
    Product Code
    JJE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SERIES OF 16 LOW LEVEL ABNORMAL TROPONIN RESULTS WAS RELEASED BY THE LABORATORY OVER A ONE HOUR AND 45 MINUTE PERIOD. AT THAT TIME AN EMERGENCY ROOM PHYSICIAN CALLED QUESTIONING RESULTS. THE ISSUE WAS INVESTIGATED AND THE ANALYZER WAS REMOVED FROM SERVICE. A BACKUP INSTRUMENT WAS USED AND RESULTS WERE CONNECTED. THE NEXT MORNING IT WAS DETERMINED BY INSTRUMENT SERVICE THAT THERE WAS A LOOSE CONNECTION AT THE INTERCONNECT FOR THE ASPIRATE PROBE #1. NO INSTRUMENT ERROR MESSAGE HAD BEEN GENERATED. PATIENT VALUES FOR CKMB (12), HCG (5), PTH (2) AND TSH (1) WERE ALSO CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS CORP. ADVIA CENTAUR *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization