BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 3252627 · Received July 19, 2013

    Report

    Report Number
    1217157-2013-00132
    Event Type
    Other
    Date Received
    July 19, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIL
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR SMOKE CAME OUT OF THE INSTRUMENT IS UNK. NEW INSTRUMENT HAS BEEN PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SMOKE CAME OUT OF THE INSTRUMENT. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338126 CLINITEK STATUS CLINITEK STATUS JIL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1