BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK 500

    MDR report key: 2962113 · Received January 22, 2013

    Report

    Report Number
    1217157-2012-00079
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LJX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER NOTES THIS IS AN INTERMITTENT PROBLEM. BIORAD QC IS RUN DAILY AND RESULTS ARE WITHIN RANGE. CUSTOMER WAS ADVISED TO CONTINUE TO CONFIRM RESULTS MICROSCOPICALLY AND VISUALLY. CUSTOMER ADVISED ON PROPER CLEANING OF THE TEST TABLE. PART NUMBER OF NEW TEST TABLE ALSO PROVIDED IF CUSTOMER WISHES TO ORDER NEW TABLE. MANUFACTURER AWAITING VERIFICATION OF IMPROVED RESULTS WITH NEW TABLE OR EFFECTIVENESS OF CLEANING CURRENT TABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS FALSE NEGATIVE LEUKOCYTES ON INSTRUMENT. WHEN SAMPLE EXAMINE MICROSCOPICALLY LEUKOCYTES ARE VISIBLE. NO REPORT OF INJURY WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31521 CLINITEK 500 CLINITEK 500 LJX SIEMENS HEALTHCARE DIAGNOSTICS CT 500

    Patients

    Seq Age Sex Outcome Treatment
    1