BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY

    MDR report key: 4997454 · Received August 12, 2015

    Report

    Report Number
    2023446-2015-00215
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 25, 2015
    Report Date
    July 25, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IRIS FIELD SERVICE ENGINEER WAS NOT SENT TO THE CUSTOMER LAB. THE CUSTOMER CONDUCTED THEIR OWN TROUBLESHOOTING AND LOCATED THE LEAK. THE CUSTOMER TIGHTENED THE FITTING AT THE CGM TO CORRECT THE ISSUE. THE CUSTOMER RERAN CONTROLS AND CONTROLS PASSED. THE SYSTEM WAS OPERATIONAL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY ARE FAILING CA AND CB QUALITY CONTROLS FOR MULTIPLE ANALYTES. THE CUSTOMER SAW LEAKING COMING FROM A FITTING CONNECTED TO THE COLOR CLARITY AND SPECIFIC GRAVITY MODULE (CGM). THERE WERE NO ERRONEOUS RESULTS GENERATED OR REPORTED OUT OF THE LAB. THE CUSTOMER STATED NO ONE WAS EXPOSED TO THE LEAK AND THE TECHNICIAN WAS WEARING GLOVES AND PPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530187 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER KQO IRIS INTERNATIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1