BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 2400

    MDR report key: 3100271 · Received May 8, 2013

    Report

    Report Number
    1823260-2013-02813
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K012397
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE PH RESULTS FOR AN UNKNOWN NUMBER OF URINE SAMPLES SINCE (B)(6) 2013. SPECIFIC DATA COULD ONLY BE PROVIDED FOR THREE SAMPLES WHICH OCCURRED ON (B)(6) 2013. THE PH RESULT FROM THE ANALYZER FOR ALL THREE SAMPLES WAS 7. WHEN MANUALLY READ, THE RESULT WAS 5. THE MANUALLY READ RESULTS WERE BELIEVED TO BE CORRECT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO PATIENTS WERE ADVERSELY AFFECTED. THE TEST STRIP LOT NUMBER WAS 21913900 WITH AN EXPIRATION DATE OF 11/30/2013. THE FIELD SERVICE REPRESENTATIVE REPLACED THE OLD AND DAMAGED BED ASSEMBLY AND REFERENCE PAD, BLEACHED THE SAMPLE LINES AND WASTE LINES AND ADJUSTED THE PHOTOMETER HEIGHT. HE ADJUSTED THE PHOTOMETER LED BRIGHTNESS AND ADJUSTED THE PROBE. HE RAN MULTIPLE CALIBRATIONS AND QC, BUT DETERMINED THE PH WOULD NOT REPORT LOWER THAN 6.5. HE THEN DETERMINED THE PHOTO HEAD ASSEMBLY WAS DEFECTIVE AND REPLACED IT. HE PERFORMED A PHOTO HEAD ALIGNMENT AND ADJUSTED THE VR OUTPUT. TO VERIFY THE ANALYZER OPERATION HE RAN TESTS, CALIBRATION AND QC WITH RESULTS WITHIN ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201404 URISYS 2400 AUTOMATED URINE ANALYZER JIL ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1