BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 1100

    MDR report key: 1920626 · Received December 13, 2010

    Report

    Report Number
    1823260-2010-07373
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    December 1, 2010
    Report Date
    May 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KHE
    PMA / PMN Number
    K033548
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE URINE ANALYZER AND STRIPS WERE RETURNED FOR INVESTIGATION. THE RETURNED MATERIALS AND RETENTION MATERIALS WERE INVESTIGATED. IT WAS DETERMINED THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION WHICH CAUSED OR CONTRIBUTED TO THE EVENT REPORTED BY THE CUSTOMER. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE NITRITE, BLOOD AND LEUKOCYTE RESULTS FOR ONE URINE SAMPLE TESTED ON THE URISYS 1100 ANALYZER. OF THE DATA PROVIDED, THE BLOOD RESULTS WERE DISCREPANT. THE INITIAL RESULT FROM THE ANALYZER WAS NEGATIVE. WHEN THE URINE CHEMSTRIP WAS TESTED MANUALLY, THE BLOOD RESULT WAS 1+ (ONE PLUS). NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT.

    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
    1 068 YR