BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK 50

    MDR report key: 2831322 · Received November 2, 2012

    Report

    Report Number
    1217157-2012-00050
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BAYER CORP.
    Product Code
    KQO
    PMA / PMN Number
    K960546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATES THAT THEY DO NOT RUN CONTROLS SO THEY DO NOT KNOW IF THE STRIPS ARE REPORTING CORRECTLY OR NOT. CUSTOMER MAINTAINS THE REAGENT STRIPS MAY HAVE BECOME DETERIORATED AND SHOULD HAVE BEEN DISCARDED. STRIP LOT EXPIRED APRIL 2012. DETERIORATED STRIPS WILL REPORT FP ON BOTH WBC AND NITRITE AND IF THEY RAN QC THEN THEY WOULD HAVE DETECTED IT. CUSTOMER WAS ASKED ABOUT THE CLEANING OF THE TEST TABLE BUT REFUSED TO DISCUSS STATING IT WAS NOT INSTRUMENT ISSUE. CUSTOMER WAS ADVISED THAT CONTROLS NEEDED TO BE RUN TO VERIFY STRIP PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS LARGE (FP) WBC AND LARGE (FP) NITRITE ON PTS BOTH VISUALLY AND INSTRUMENTALLY. ANTIBIOTICS WERE ADMINISTERED BASED ON RESULT SUSPECT UTI BUT NO HARM TO PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK 50 CLINITEK 50 KQO BAYER CORP. CT 50

    Patients

    Seq Age Sex Outcome Treatment
    1