BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP 10 UA

    MDR report key: 2074923 · Received May 3, 2011

    Report

    Report Number
    1823260-2011-02349
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 8, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIO
    PMA / PMN Number
    K896454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION WITH THE USER'S DEVICE SHOWED THAT THE VALUES WERE SLIGHTLY LOWER IN COMPARISON TO A REFERENCE METHOD. HOWEVER, THE DIFFERENCE WAS NOT POTENTIALLY CRITICAL AND WAS NOT A RISK FOR THE USER OR THE PATIENT. THE SUSPECT TRAY WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, NO SPECIFIC ROOT CAUSE COULD BE DETERMINED. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER STATING THE ASSAY INVOLVED WAS LEUKOCYTES, NOT ERYTHROCYTES AS PREVIOUSLY REPORTED ON THE INITIAL MEDWATCH. THE REPEAT RESULT ON A "CUA" WAS "++" WHICH THE USER STATED EQUALS 500 LEU/UL. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN WHO ORDERED TESTING IN THE LABORATORY TO CONFIRM THE NEGATIVE RESULT.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE ERYTHROCYTE RESULT FOR ONE PATIENT URINE SAMPLE FROM THE URISYS 1100 URINE ANALYZER (B)(4). THE INITIAL RESULT WAS NEGATIVE. THE RESULT FROM THE LABORATORY ON A "CUA" WITH THE SAME LOT NUMBER OF CHEMSTRIPS WAS "++" AND A VISUAL READING OF THE CHEMSTRIP WAS ALSO POSITIVE. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE USER STATED SHE THOUGHT THE ISSUE MAY HAVE BEEN CAUSED BY THE TRAY ON THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMSTRIP 10 UA METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) JIO ROCHE DIAGNOSTICS NA 20031104

    Patients

    Seq Age Sex Outcome Treatment
    1