BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 CK-MB ASSAY

    MDR report key: 1208540 · Received October 15, 2008

    Report

    Report Number
    2017183-2008-00040
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 18, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS LTD.
    Product Code
    JHX
    PMA / PMN Number
    K034055
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 AND INSTRUMENT DATA INDICATE THAT THERE ARE NO KNOWN CAUSE FOR THE DISCORDANT CK-MB RESULTS. IT'S SUSPECTED THAT FIBRIN IN THE SAMPLES MAY HAVE CAUSED THE DISCREPANT RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A POSITIVE IMMULITE 2500 CK-MB RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES. UPON REPEAT, THE RESULTS WERE NEGATIVE WHICH DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CK-MB RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THERE ARE NO KNOWN CAUSE FOR THE DISCORDANT CK-MB RESULTS. IT'S SUSPECTED THAT FIBRIN IN THE SAMPLES MAY HAVE CAUSED THE DISCREPANT RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    A POSITIVE IMMULITE 2500 CK-MB RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES. UPON REPEAT, THE RESULTS WERE NEGATIVE WHICH DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CK-MB RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THERE ARE NO KNOWN CAUSE FOR THE DISCORDANT CK-MB RESULTS. IT'S SUSPECTED THAT FIBRIN IN THE SAMPLES MAY HAVE CAUSED THE DISCREPANT RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    A POSITIVE IMMULITE 2500 CK-MB RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES. UPON REPEAT, THE RESULTS WERE NEGATIVE WHICH DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CK-MB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 CK-MB ASSAY CK-MB IMMUNOASSAYS JHX SIEMENS HEALTHCARE DIAGNOSTICS LTD. NA 126

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3