BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP® 10 UA

    MDR report key: 2669198 · Received July 25, 2012

    Report

    Report Number
    1823260-2012-03829
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    July 10, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LJX
    PMA / PMN Number
    K896454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE INITIAL RESULT WAS "NEGATIVE" FOR LEUKOCYTES ON THE CHEMSTRIP 10 UA. THE RESULT FROM THE IRIS LAB INSTRUMENT CAME UP AS 1+ WHICH IS 250-500 LEUKOCYTES PER MICROLITER. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. THE CALLER DID NOT HAVE ANY SPECIFIC PATIENT TREATMENT INFORMATION. NO ACTIONS WERE REPORTED TAKEN BASED ON EITHER TEST. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMSTRIP® 10 UA METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) LJX ROCHE DIAGNOSTICS NA 21155101

    Patients

    Seq Age Sex Outcome Treatment
    1 041 YR