BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCS(R) XP

    MDR report key: 4995243 · Received August 12, 2015

    Report

    Report Number
    9610806-2015-00026
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GKP
    PMA / PMN Number
    K970431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCREPANT PT AND APTT RESULTS IS USER ERROR. THE CUSTOMER WAS DOING MAINTENANCE FOR DISINFECTION AND FORGOT TO PUT THE DIP TUBE BACK IN THE WATER CONTAINER AFTER COMPLETING THE PROCESS. WHEN THEY RAN CONTROLS THEY REALIZED THAT THE DIP TUBE WAS STILL IN THE DISINFECTANT SOLUTION. THEY DETECTED THEIR ERROR WHEN THE CONTROLS RECOVERED OUT OF RANGE. THE CUSTOMER CORRECTED THEIR ERROR BY PLACING THE DIP TUBE IN THE PROPER CONTAINER, FLUSHING OUT THE DISINFECTANT, AND RUNNING CONTROLS. LOOKBACK WAS PERFORMED ON PATIENTS RUN BETWEEN THE INCORRECT POSITIONING OF THE DIP TUBE AND RUNNING CONTROLS. THE INSTRUMENT AND PT AND APTT REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATION. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    DISCREPANT PROTHROMBIN TIME (PT) AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) PATIENT AND QC RESULTS WERE OBTAINED ON THE BCS XP INSTRUMENT. PATIENT RESULTS WERE REPORTED AND QUESTIONED AFTER QC WAS DETECTED TO BE OUT OF LABORATORY RANGES. CORRECTED RESULTS WERE ISSUED FOR PATIENTS AFTER A USER ERROR WAS DETECTED BY THE OUT OF RANGE QC RESULTS. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCREPANT PATIENT RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530573 BCS(R) XP BCS(R) XP GKP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1