BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSENSOR CREATININE HOSPITAL METER

    MDR report key: 1593542 · Received January 27, 2010

    Report

    Report Number
    1219029-2010-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 18, 2010
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CGL
    PMA / PMN Number
    K070068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT CREATININE RESULT FROM A STATSENSOR METER WAS 1.1 MG/DL VERSUS A RESULT OF 3.0 MG/DL FROM A BECKMAN DXC ANALYZER. SAMPLE TYPE PLASMA FROM A GREEN TOP TUBE. QUALITY CONTROL RUN BEFORE AND AFTER THE EVENT WERE ACCEPTABLE. NO MAINTENANCE WAS DONE TO DEVICE BEFORE OR AFTER THE EVENT. AFTER THE REPORTED EVENT COMPARISON TESTING WAS PERFORMED BETWEEN THE STATSENSOR METER AND THE BECKMAN DXC ANALYZER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATSENSOR CREATININE HOSPITAL METER CGL - ELECTRODE, ION BASED, ENZYMATIC CR CGL NOVA BIOMEDICAL 44011 - METER STRIP - 4909317249

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN