BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM 1--

    MDR report key: 4748982 · Received May 1, 2015

    Report

    Report Number
    2023446-2015-00144
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    IRIS INT'L
    Product Code
    JIL
    PMA / PMN Number
    K060280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THE LAST TWO DIGITS OF PT BARCODES ARE BEING READ INCORRECTLY BY THE INSTRUMENT. THERE ARE NO REPORTS OF ERRONEOUS RESULTS BEING GENERATED OR REPORTED OUT OF THE LAB. THE CUSTOMER WAS SENT A REPLACEMENT INSTRUMENT TO RESOLVE THE ISSUE. THE NEW SYSTEM WAS OPERATIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE LAST TWO DIGITS OF PT BARCODES ARE BEING READ INCORRECTLY BY THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289446 ICHEM 1-- URINE CHEMISTRY ANALYZER JIL IRIS INT'L

    Patients

    Seq Age Sex Outcome Treatment
    1