BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCS(R) XP

    MDR report key: 3163377 · Received June 11, 2013

    Report

    Report Number
    9610806-2013-00011
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GKP
    PMA / PMN Number
    K970431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCREPANT PT INR RESULTS IS UNDER INVESTIGATION. THE SIEMENS DIAGNOSTICS INC. FIELD SERVICE ENGINEER EXAMINED THE INSTRUMENT AND FOUND AN INSTRUMENT ISSUE, A BLOCKED FILTER IN THE WATER LINE WHICH MAY HAVE CONTRIBUTED TO THE EVENT. SUBSEQUENTLY, ADDITIONAL ANALYSIS OF RESULTS FROM THE AFFECTED INSTRUMENT SHOWED A MISALIGNMENT CAUSING A SAMPLE SHIFT BY ONE POSITION. ANALYSIS OF INSTRUMENT FILES REVEALED A BARCODE AND RACK MOVING ERROR. THE COMPLAINT IS UNDER FURTHER INVESTIGATION. NO SIMILAR COMPLAINTS ON OTHER BCS-XP INSTRUMENTS HAVE BEEN FILED. THE AFFECTED INSTRUMENT HAS BEEN DECOMMISSIONED AT THE CUSTOMER SITE AND THE UNAFFECTED ALTERNATE BCS-XP INSTRUMENT IS IN USE.

    Description of Event or Problem · 1

    DISCREPANT PROTHROMBIN TIME (PT) INR RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND RESULTS WERE OBTAINED IN AGREEMENT WITH PHYSICIAN EXPECTATIONS. CORRECTED REPORTS WERE ISSUED. IN THE CASE OF ONE PATIENT WITH A FALSELY ELEVATED PT INR REPORTED, TREATMENT WITH THE ORAL ANTICOAGULANT MARCUMAR WAS ALTERED. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENTS AS A RESULT OF THE DISCREPANT PT INR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264128 BCS(R) XP BCS(R) XP GKP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 180672

    Patients

    Seq Age Sex Outcome Treatment
    1