BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 2860281 · Received November 9, 2012

    Report

    Report Number
    1217157-2012-00058
    Event Type
    Other
    Date Received
    November 9, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJW
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTS THAT QUALITY CONTROL LOTS BEING USED ARE WITHIN THEIR EXPIRATION DATING. ROUTINE EXAM OF THE INSTRUMENT WAS PERFORMED. CALIBRATION BAR WAS CHECKED FOR DISCOLORATION, SCRATCHES OR DAMAGE. QUALITY CONTROL STRIPS WERE CHANGED TO A NEW LOT. CALIBRATION BAR AND TEST TABLE WERE CLEANED WITH DISTILLED WATER. CUSTOMER WAS SENT A CUSTOMER BULLETIN ON RECOMMENDED CONTROLS FOR USE AS CUSTOMER WAS USING MAS CONTROLS WHICH ARE NOT RECOMMENDED. CUSTOMER WAS TOLD TO MONITOR THE RESULTS FOR FURTHER FALSE NEGATIVE RESULTS. THEY WERE FURTHER ADVISED TO PERFORM A VISUAL READ-DO NOT LOOK AT THE TESTING STRIP TO DETERMINE IF THE SAMPLE IS NEGATIVE OR POSITIVE. IN ADDITION, THEY WERE ADVISED TO DIP THE STRIP SETTING THE TIMER AT THE SAME TIME, RIM THE STRIP AND READ THE LEUKOCYTE AT THE TWO MINUTE MARK.

    Description of Event or Problem · 1

    FALSE NEGATIVE WHITE BLOOD CELLS ON MAS QC CONTROL AND PATIENT WITH MULTISTIX 10 SG. CUSTOMER STATED THAT IT IS UNKNOWN IF PATIENT CARE WAS DELAYED/IMPACTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK STATUS CT STATUS JJW SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1