BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP® 10 UA

    MDR report key: 2183638 · Received July 29, 2011

    Report

    Report Number
    1823260-2011-04081
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K896454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE URINALYSIS RESULTS FOR ONE PATIENT SAMPLE FROM THE URISYS 1100 ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR GLUCOSE AND PROTEIN WERE DISCREPANT. THE INITIAL RESULT WAS "NEGATIVE" FOR BOTH GLUCOSE AND PROTEIN ON THE URISYS 1100 ANALYZER SERIAL NUMBER (B)(4). THE RESULT FROM THE URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) WAS 250 FOR GLUCOSE AND 100 FOR PROTEIN (UNITS WERE NOT PROVIDED). NO INFORMATION WAS PROVIDED ABOUT THE PATIENT. THE USER STATED THAT THEY WENT WITH THE NEGATIVE PATIENT RESULTS FOR BOTH GLUCOSE AND PROTEIN. THERE WAS NOT A WAY TO CONFIRM THAT THE NEGATIVE RESULTS WERE CORRECT. THERE WAS NOT A LABORATORY TEST DONE ON THE PATIENT INVOLVED.

    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 20418302

    Patients

    Seq Age Sex Outcome Treatment
    1