BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPC IMMULITE 1000

    MDR report key: 555046 · Received September 13, 2004

    Report

    Report Number
    MW1033216
    Event Type
    Malfunction
    Date Received
    September 13, 2004
    Date of Event
    August 30, 2004
    Report Date
    September 1, 2004
    Manufacturer
    DIAGNOSTICS PRODUCTS CORP
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER CHANGED THE DESIGN OF REAGENT WEDGE CAPS IN OCT. OF 2003. THE NEW CAPS ALLOW THE SAMPLE PROBE TO GO DOWN FURTHER THAN THE OLD CAPS. IF THE OPERATOR FORGETS TO OPEN THE REAGENT WEDGE CAP, THE SOFTWARE DOES NOT ALWAYS DETECT THAT THE CAP WAS CLOSED. THE INSTRUMENT PROCESSES A SPECIMEN WITH NO ERROR CODES AND AN ERRONEOUS RESULT OF BELOW DETECTABLE LEVEL CAN BE TURNED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DPC IMMULITE 1000 IMMUNOASSAY ANALYZER KHO DIAGNOSTICS PRODUCTS CORP 030001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *