BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1865208 · Received October 5, 2010

    Report

    Report Number
    2247117-2010-00037
    Event Type
    Other
    Date Received
    October 5, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 13, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT PROBNP RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    TWO (2) DISCORDANT LOW IMMULITE 2500 PROBNP PT RESULTS WERE OBTAINED ON TWO DIFFERENT PT SAMPLES. THE LABORATORY HAD BEEN REPEATING ALL PROBNP RESULTS <600 SINCE THEY HAD BEEN TROUBLE SHOOTING THE SYSTEM. THE REPEAT PROBNP RESULTS FIT THE CLINICAL PICTURE FOR BOTH PTS. THE INITIAL DISCORDANT LOW RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROBNP RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT PROBNP RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    TWO (2) DISCORDANT LOW IMMULITE 2500 PROBNP PT RESULTS WERE OBTAINED ON TWO DIFFERENT PT SAMPLES. THE LABORATORY HAD BEEN REPEATING ALL PROBNP RESULTS <600 SINCE THEY HAD BEEN TROUBLE SHOOTING THE SYSTEM. THE REPEAT PROBNP RESULTS FIT THE CLINICAL PICTURE FOR BOTH PTS. THE INITIAL DISCORDANT LOW RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROBNP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2