BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP® 10 UA

    MDR report key: 2141548 · Received June 27, 2011

    Report

    Report Number
    1823260-2011-03468
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K896454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRITERION II URINE ANALYZER WAS RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE DISCRPANCIES WAS NOT DETERMINED. BOTH POSITIVE AND NEGATIVE CONTROLS PRODUCED EXPECTED RESULTS. FURTHER INVESTIGATION USING RETENTION MATERIAL (FROM THE SAME REAGENT LOT NUMBER) MEASURED VALUES THAT WERE ALL WITHIN SPECIFIED RANGES. THE CUSTOMER MATERIAL WAS NOT INVESTIGATED SINCE IT WAS NOT PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE URINE LEUKOCYTE RESULTS FOR TWO PATIENT SAMPLES. THE URINE LEUKOCYTE RESULTS FOR ONE SAMPLE WERE DIECREPANT. THE SAMPLE WAS A CLEAN CATCH URINE SAMPLE COLLECTED AT AN OFF-SITE CLINIC. THE SAMPLE WAS PALE YELLOW AND CLEAR AT ROOM TEMPERATURE. THE PATIENT'S INITIAL URINE LEUKOCYTE RESULT WAS NEGATIVE WHEN TESTED ON A CRITERION II URINE ANALYZER, SERIAL NUMBER (B)(4). THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. WHEN THE URINE SAMPLE WAS EVALUATED MICROSCOPICALLY, THE WHITE BLOOD CELL COUNT WAS 11-20/HPF. A CALIBRATION WAS PERFORMED AND THE SAMPLE WAS RETESTED TWICE ON THE CRITERION II URINE ANALYZER. THE LEUKOCYTE RESULT WAS NEGATIVE BOTH TIMES. NO VISUAL READING WAS PERFORMED. THE INITIAL NEGATIVE LEUKOCYTE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. A REQUEST TO RETURN THE CRITERION II URINE ANALYZER TO ROCHE FOR EVALUATION HAS BEEN COMMUNICATED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMSTRIP® 10 UA METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) JIL ROCHE DIAGNOSTICS NA 20320101

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR