BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+ ANALYZER

    MDR report key: 3793883 · Received May 6, 2014

    Report

    Report Number
    1217157-2014-00063
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOTICS
    Product Code
    LJX
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR DISCORDANT LEUKOCYTE RESULTS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    VISUAL EXAM BY TECH OPERATIONS OF RETURNED INSTRUMENT SHOWED NO OBVIOUS DAMAGE OR UNDUE WEAR. TEST WITH STATUS CHECK CASSETTE INDICATED NORMAL UNIT FUNCTIONALITY. PERFORMANCE TEST OF RETURNED & COMPARISON INSTRUMENT WITH MULTISTIX 10SG REAGENT DONE WITH TEST SOLUTIONS CONTRIVED TO 5 & 10 WBC/MCL. N=12 REPS EACH TEST SOLUTION, EACH INSTRUMENT. BOTH RETURNED & COMPARISON INSTRUMENT GAVE SIMILAR RESULTS. ALL STRIPS TESTED AT 10 WBC/MCL REPORTED AS POSITIVE, AS DID MAJORITY TESTED AT 5 WBC/MCL. INSTRUMENT RESULTS AGREED WITH VISUAL OBSERVATION OF TESTED STRIPS. CUSTOMER DID NOT RETURN REAGENT USED IN ORIGINAL RESULTS. CUSTOMER OBSERVATION OF FALSE NEGATIVE LEUKOCYTE FROM CLINITEKSTATUS+ S/N (B)(4) USING MULTISTIX 10SG REAGENT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO FALSE NEGATIVE LEUKOCYTE RESULTS ON INSTRUMENT, WHEREAS REFERENCE LAB RESULTS WERE POSITIVE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270769 CLINITEK STATUS+ ANALYZER CT STATUS+ ANALZER LJX SIEMENS HEALTHCARE DIAGNOTICS

    Patients

    Seq Age Sex Outcome Treatment
    1