BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALBUSTIX

    MDR report key: 3131278 · Received May 13, 2013

    Report

    Report Number
    1217157-2013-00075
    Event Type
    Other
    Date Received
    May 13, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 17, 2013
    Manufacturer
    KIMBALL ELECTRONICS
    Product Code
    CHL
    PMA / PMN Number
    K002738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR DISCORDANT PROTEIN RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT PROTEIN RESULTS WITH ALBUSTIX URINE TEST STRIPS. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211713 ALBUSTIX ALBUSTIX CHL KIMBALL ELECTRONICS 210023

    Patients

    Seq Age Sex Outcome Treatment
    1