BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TOXOPLASMA M ASSAY

    MDR report key: 1366355 · Received April 20, 2009

    Report

    Report Number
    1219913-2009-00044
    Event Type
    Other
    Date Received
    April 20, 2009
    Date of Event
    March 27, 2009
    Report Date
    April 3, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K010755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM EVAL. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TOXO M RESULT IS UNK. THE QC PERFORMANCE DATA FOR TOXO M LOT 175 AND LOT 177 MET QC FINAL RELEASE SPECIFICATIONS. THERE HAS BEEN NO OTHER REPORTED ADVIA CENTAUR TOXO M FALSE NEGATIVE CUSTOMER COMPLAINTS FOR REAGENT LOT 175. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE NEGATIVE ADVIA CENTAUR TOXOPLASMA M WAS OBTAINED AND REPORTED ON A PT SAMPLE. THE CUSTOMER PERFORMED REPEAT TOXO M TESTING WITH A NEW REAGENT LOT AND THE RESULT WAS POSITIVE. THE PT SAMPLE WAS RUN TEN TIMES WITH THE NEW REAGENT LOT AND THE RESULTS WERE ALL POSITIVE. THE FINAL PT RESULT WAS REPORTED AS POSITIVE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXO M RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TOXOPLASMA M ASSAY TOXOPLASMA M (TOXO M) IMMUNOASSAY MMI SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS INC. NA 175

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR