BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCS XP

    MDR report key: 5063713 · Received September 9, 2015

    Report

    Report Number
    9610806-2015-00031
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 11, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GKP
    PMA / PMN Number
    K970431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCREPANT FALSELY DEPRESSED FACTOR V RESULT IS UNKNOWN. OPERATOR ERROR CONTRIBUTED TO THE REPORTING OF A DISCREPANT RESULT. INVALID FLAGGED RESULTS SHOULD NOT BE REPORTED PER OPERATOR'S GUIDE INSTRUCTIONS. THE GROSSLY DEPRESSED RESULT IS HIGHLY SUGGESTIVE OF A SAMPLE INTEGRITY ISSUE. THE SAMPLE WAS DRAWN AT A SEPARATE FACILITY. THE CONCORDANT REPEAT RESULT WAS OBTAINED AFTER RE-CENTRIFUGATION OF THE SAMPLE. A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND FOUND NO INSTRUMENT MALFUNCTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED FACTOR V (FV) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE BCS XP INSTRUMENT. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE REPEAT TEST ON THE SAME SAMPLE GAVE A HIGHER RESULT IN THE NORMAL REFERENCE RANGE.. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED FACTOR V RESULT. THERE IS NO REPORT OF ADVERSE OUTCOME TO PATIENTS AS A RESULT OF THE FALSELY DEPRESSED FACTOR V RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595383 BCS XP BCS XP GKP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1