BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK STATUS+

    MDR report key: 5656440 · Received May 16, 2016

    Report

    Report Number
    1217157-2016-00056
    Date Received
    May 16, 2016
    Date of Event
    April 7, 2016
    Report Date
    May 16, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER PERFORMED A VISUAL READ COMPARED TO THE INSTRUMENT ON FRIDAY FOR 5 CONSECUTIVE SAMPLES AND SHE FOUND THAT THE STATUS+ INSTRUMENT READ VS VISUAL READ CORRELATED CONSISTENTLY BUT IT DID NOT MATCH WITH THE AUW100 (LIS). SIEMENS REPRESENTATIVE SPOKE TO CUSTOMER WHO HAS NOTICED THAT SINCE AUW100 REAGENT WAS CHANGED FROM REAGENT LOT# K243125 TO K258026 THE TWO INSTRUMENTS (CLINITEK STATUS+ AND NOVUS) RESULTS HAVE AGREED WITH EACH OTHER. CUSTOMER IS SATISFIED AND REQUIRES NO FURTHER FOLLOW UPS. THE INSTRUMENT AND MULTISTIX ARE PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT LEUKOCYTES RESULTS WERE OUT OF RANGE WHILE RUNNING CORRELATION TESTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311565 CLINITEK STATUS+ CT STATUS+ JIL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1