BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1874232 · Received October 12, 2010

    Report

    Report Number
    2247117-2010-00045
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE DISCORDANT TSH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT IMMULITE 2500 TSH RESULTS WERE OBTAINED WITH MULTIPLE PATIENT SAMPLES. UPON REVIEW BY THE INTERNAL LAB SUPERVISOR, MANY LOW SAMPLES WERE NOTED. REPEAT TESTING WAS PERFORMED, AND AMENDED REPORTS WERE SENT TO THE PHYSICIANS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE DISCORDANT TSH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT IMMULITE 2500 TSH RESULTS WERE OBTAINED WITH MULTIPLE PATIENT SAMPLES. UPON REVIEW BY THE INTERNAL LAB SUPERVISOR, MANY LOW SAMPLES WERE NOTED. REPEAT TESTING WAS PERFORMED, AND AMENDED REPORTS WERE SENT TO THE PHYSICIANS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE DISCORDANT TSH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    DISCORDANT IMMULITE 2500 TSH RESULTS WERE OBTAINED WITH MULTIPLE PATIENT SAMPLES. UPON REVIEW BY THE INTERNAL LAB SUPERVISOR, MANY LOW SAMPLES WERE NOTED. REPEAT TESTING WAS PERFORMED, AND AMENDED REPORTS WERE SENT TO THE PHYSICIANS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH RESULTS.

    Additional Manufacturer Narrative · 4

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE DISCORDANT TSH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 4

    DISCORDANT IMMULITE 2500 TSH RESULTS WERE OBTAINED WITH MULTIPLE PATIENT SAMPLES. UPON REVIEW BY THE INTERNAL LAB SUPERVISOR, MANY LOW SAMPLES WERE NOTED. REPEAT TESTING WAS PERFORMED, AND AMENDED REPORTS WERE SENT TO THE PHYSICIANS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH RESULTS.

    Additional Manufacturer Narrative · 5

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE DISCORDANT TSH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 5

    DISCORDANT IMMULITE 2500 TSH RESULTS WERE OBTAINED WITH MULTIPLE PATIENT SAMPLES. UPON REVIEW BY THE INTERNAL LAB SUPERVISOR, MANY LOW SAMPLES WERE NOTED. REPEAT TESTING WAS PERFORMED, AND AMENDED REPORTS WERE SENT TO THE PHYSICIANS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH RESULTS.

    Additional Manufacturer Narrative · 6

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE DISCORDANT TSH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 6

    DISCORDANT IMMULITE 2500 TSH RESULTS WERE OBTAINED WITH MULTIPLE PATIENT SAMPLES. UPON REVIEW BY THE INTERNAL LAB SUPERVISOR, MANY LOW SAMPLES WERE NOTED. REPEAT TESTING WAS PERFORMED, AND AMENDED REPORTS WERE SENT TO THE PHYSICIANS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH 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
    3
    4
    5
    6