BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 1100

    MDR report key: 5198408 · Received November 3, 2015

    Report

    Report Number
    1823260-2015-04438
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    October 8, 2015
    Report Date
    January 5, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KHE
    PMA / PMN Number
    K033548
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE URISYS DEVICE WITH THE SERIAL NUMBER (B)(4) WAS RECEIVED. THERE WERE NO NOTICEABLE DEFECTS TO BE SEEN. THE RETENTION MATERIAL OF LOT 233 488 00 WAS TESTED ON THE CUSTOMER DEVICE AND AN INVESTIGATION UNIT URISYS 1100 DEVICE. THERE WERE NO FALSE NEGATIVE RESULTS OBSERVED. THE MEASUREMENTS ON THE CUSTOMER DEVICE AND THE INVESTIGATION UNIT DEVICE ARE COMPARABLE.

    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 PRODUCED NEGATIVE RESULTS FOR LEUKOCYTES AND ERYTHROCYTES, WHILE A VISUAL READ OF THE TEST STRIP SHOWED VALUES OF 500 LEUKOCYTES/MICROLITER AND 250 ERYTHROCYTES/MICROLITER 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
    728806 URISYS 1100 AUTOMATED URINE ANALYZER KHE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1