BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2364677 · Received December 9, 2011

    Report

    Report Number
    2247117-2011-00081
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 12, 2011
    Report Date
    November 22, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    NBC
    PMA / PMN Number
    K970227
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS TSE (TECHNICAL SERVICE ENGINEER) EVALUATED THE INSTRUMENT DATA. AFTER EVALUATING THE INSTRUMENT DATA, THE TSE CONCLUDED THAT THE CAUSE OF THE DISCORDANT NTPROBNP RESULT IS UNKNOWN. NO CONCLUSIONS CAN BE DRAWN AS TO WHAT CAUSED THE DISCORDANT LOW NTPROBNP RESULT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED

    Description of Event or Problem · 1

    A DISCORDANT LOW NTPROBNP (N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE ) RESULT WAS OBTAINED WITH ONE (1) PATIENT SAMPLE ON AN IMMULITE 2000 ANALYZER. DUE TO THE PATIENT'S CLINICAL PICTURE, THE LAB CONSIDERED THE NTPROBNP RESULT TO BE DISCORDANT WITH THE PATIENT'S ADVIA BNP RESULT OBTAINED (WITH THE SAME SAMPLE) ON AN ADVIA CENTAUR XP ANALYZER. THE DISCORDANT NTPROBNP RESULT WAS RELEASED TO THE PHYSICIAN. THE PATIENT'S SAMPLE WAS DISCARDED AND IMMULITE 2000 NTPROBNP TESTING COULD NOT BE REPEATED. THERE WAS NO KNOWN REPORT OF PATIENT CARE BEING ALTERED OR PRESCRIBED DUE TO THE DISCORDANT NTPROBNP RESULT. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NTPROBNP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY NBC SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1