BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK STATUS+

    MDR report key: 4562485 · Received March 3, 2015

    Report

    Report Number
    1217157-2015-00026
    Date Received
    March 3, 2015
    Date of Event
    January 22, 2015
    Report Date
    February 2, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K032563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED BARCODES WERE RECEIVED AND THEY ARE IN PROCESS OF INVESTIGATION. THE CAUSE FOR THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT BARCODE SCANNER WAS NOT CODING CORRECTLY. CUSTOMER EXPLAINED THAT WHEN BARCODE LABEL WILL BE SCANNED, IT WILL INTERMITTENTLY REPLACE IDS WITH LETTER H WITH LETTER J. CUSTOMER STATED THAT THEY ARE INTERFACED WITH MEDITECH AND USE QML AS MIDDLEWARE. SHE STATED THAT THEY HAVE TRIED TO SCAN FLAT LABELS AS WELL AS APPLYING LABEL BARCODE TO SAMPLE CUP AND SCANNING THAT WAY AND SAME ERROR OCCURRED. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145604 CLINITEK STATUS+ CT STATUS+ JIL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1