BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY CONTROL

    MDR report key: 3636136 · Received December 11, 2013

    Report

    Report Number
    2023446-2013-00034
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    August 31, 2013
    Report Date
    December 11, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JJW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    2023446-2013-00034 . IRIS PRODUCT IFU INSERT STATES THAT THE DIAGNOSTIC OR THERAPEUTIC DECISIONS SHOULD NOT BE BASED ON ANY SINGLE RESULT OR METHOD. NO REPORTS OF CHANGE IN PATIENT MANAGEMENT OR INJURIES WERE REPORTED. THE FOLLOWING MDRS ARE RELATED TO THIS EVENT. 2023446-2013-0024, -00025, -00026, -00027, -00028, -00029, -00030, -00031, -00032, -00033, -0034, -00035, -00036, -00037, -00038, -00039, -00040, -00041, -00042.

    Description of Event or Problem · 1

    CUSTOMER GETTING DISCORDANT RESULTS WITH 20 PATIENTS BETWEEN ICHEM VELOCITY (NEGATIVE) AND IQ200 (POSITIVE). CUSTOMER REPORTED THAT ONE PATIENT SAMPLE WAS NEGATIVE ON CHEMISTRY AND HAD >45 RBC'S. THE OTHER 19 PATIENT SAMPLES WERE ALSO NEGATIVE ON CHEMISTRY AND HAD APPROXIMATELY 5 RBC'S. THE PRESENCE OF RBC'S WAS CONFIRMED WITH MANUAL MICROSCOPE IN ALL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649064 ICHEM VELOCITY CONTROL ICHEM VELOCITY CONTROL JJW IRIS INTERNATIONAL 213-13

    Patients

    Seq Age Sex Outcome Treatment
    1 Other