BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS +

    MDR report key: 3981095 · Received August 5, 2014

    Report

    Report Number
    1217157-2014-00104
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 14, 2014
    Manufacturer
    SIEMENS HEALTHECARE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS UNSURE WHICH OF THE FOUR TESTS RESULTS FOR THE CHILD WERE CORRECT. INSTRUMENT AND VISUAL TESTING DONE ONLY, PATIENT SAMPLE WAS NOT SENT TO REFERENCE LAB. CUSTOMER INDICATED SAMPLES WERE DISCARDED. CUSTOMER WAS GIVEN INSTRUCTIONS ON HOW TO COMPLETE TESTING ON INSTRUMENT AND PERFORM QC CORRECTLY USING CHEK-STIX. CUSTOMER SUCCESSFULLY PREPARED CHEK-STIX AND QC IS IN RANGE. INSTRUMENT IS OPERATIONAL PER CUSTOMER INPUT.

    Description of Event or Problem · 1

    CUSTOMER IS GETTING DISCREPANT RESULTS FOR ONE PATIENT ON PROTEIN, GLUCOSE, AND NITRITE RESULTS. CUSTOMER ALSO HAD 15 CHILD PATIENTS WITH POSITIVE PROTEIN RESULTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457266 CLINITEK STATUS + CT STATUS + JIL SIEMENS HEALTHECARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1