BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR MYOGLOBIN (MYO)

    MDR report key: 1334966 · Received March 4, 2009

    Report

    Report Number
    1219913-2009-00022
    Event Type
    Other
    Date Received
    March 4, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 17, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DDR
    PMA / PMN Number
    K974325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATED THAT THE SAMPLE PROBE VERTICAL PULLEY NEEDED ADJUSTMENT. THE FSE READJUSTED AND TIGHTENED THE VERTICAL PULLEY AND RECALIBRATED THE SAMPLE PROBE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    TWO FALSELY SUPPRESSED ADVIA CENTAUR MYOGLOBIN RESULTS WERE OBTAINED ON PT SAMPLES. REPEAT TESTING WAS PERFORMED ON THE PT SAMPLES AND THE TEST RESULTS WERE HIGHER. THE SECOND PT SAMPLE WAS TESTED ON THE ADVIA CENTAUR CP AND THE RESULT WAS MUCH HIGHER THAN THE REPEAT ON THE ADVIA CENTAUR. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT MYOGLOBIN RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND VERTICAL PULLEY NEEDED ADJUSTMENT. THE FSE READJUSTED AND TIGHTENED THE VERTICAL PULLEY AND RECALIBRATED THE SAMPLE PROBE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    TWO FALSELY SUPPRESSED ADVIA CENTAUR MYOGLOBIN RESULTS WERE OBTAINED ON PT SAMPLES. REPEAT TESTING WAS PERFORMED ON THE PT SAMPLES AND THE TEST RESULTS WERE HIGHER. THE SECOND PT SAMPLE WAS TESTED ON THE ADVIA CENTAUR CP AND THE RESULT WAS MUCH HIGHER THAN THE REPEAT ON THE ADVIA CENTAUR. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT MYOGLOBIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR MYOGLOBIN (MYO) MYOGLOBIN IMMUNOASSAY DDR SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 055160

    Patients

    Seq Age Sex Outcome Treatment
    1
    2