BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 1100

    MDR report key: 2840649 · Received November 20, 2012

    Report

    Report Number
    1823260-2012-05900
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KHE
    PMA / PMN Number
    K033548
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE INITIAL REPORTER HAS OR INTENDS TO REPORT THE EVENT TO FDA.

    Description of Event or Problem · 1

    REPORTER STATED THAT THE URISYS 1100 INSTRUMENT REPORTED NEGATIVE RESULTS FOR PROTEIN, BLOOD, AND LEUKOCYTES, WHILE A VISUAL READING OF THE TEST STRIP SHOWED 500 MG/DL, 250 ERY/MICROLITER, AND ++ (2+), RESPECTIVELY. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URISYS 1100 AUTOMATED URINE ANALYZER KHE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1