BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 3054936 · Received April 3, 2013

    Report

    Report Number
    1217157-2013-00050
    Event Type
    Other
    Date Received
    April 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    CHL
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE NIH PT ID NUMBER CANNOT BE ENTERED INTO THE INSTRUMENT MANUALLY, IT MUST BE ENTERED BY SCANNING A NON-SIEMENS GENERATED BARCODE. THE SYSTEM BARCODE READER WAS CHECKED AND FOUND TO BE CLEAN. THE CONNECTION WAS CHECKED AND FOUND TO BE CORRECT. TEST BARCODES READ CORRECTLY. THE BARCODES IN QUESTION HAD BEEN THROWN AWAY, SO THEY COULD NOT BE TESTED BY A SIEMENS FIELD ENGINEER. A NEWLY GENERATED NHI ID BARCODE WAS SCANNED OVER 30 TIMES FORM A FLAT BARCODE, AND ALL SCANS WERE CORRECT. WHEN A BARCODE THAT HAD BEEN PLACED ON A CONTAINER AND HAD A SLIGHT CURVE TO IT, THERE WAS ONE ERROR OUT OF THE 30 SCANS RUN.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT WHEN SCANNING A NON-SIEMENS MADE BARCODE THAT IS USED TO ENTER A UNIQUE NHI PT ID NUMBER FOR A URINE SAMPLE INTO THE INSTRUMENT, IT DID NOT SCAN INTO THE INSTRUMENT AS THE SAME NUMBER ON THE BARCODE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135508 CLINITEK STATUS CT STATUS CHL SIEMENS HEALTHCARE DIAGNOSTICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1