BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITAK STATUS

    MDR report key: 3488861 · Received October 31, 2013

    Report

    Report Number
    1217157-2013-00200
    Event Type
    Other
    Date Received
    October 31, 2013
    Date of Event
    September 8, 2013
    Report Date
    October 8, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIR
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS BEING EXPLANTED FOR PROPER SAMPLE TECHNIQUE. BASED ON THE DISCUSSION WITH CUSTOMER, SIEMENS REPRESENTATIVE FOUND OUT THAT CUSTOMER WAS ON AZO WHICH CAN AFFECT THE READABILITY OF THE TEST PADS. INSTRUMENT IS OPERATIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NEGATIVE LEUKOCYTES RESULTS ON THE INSTRUMENT. CUSTOMER INDICATED THAT THEY RUN QUALITY CONTROL AFTER TESTING PT SAMPLE ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560649 CLINITAK STATUS CT STATUS JIR SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1