BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABOTT I-STAT MACHINE

    MDR report key: 2033557 · Received March 3, 2011

    Report

    Report Number
    2033557
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD SEVERAL PATIENTS WHOSE SERUM CREATININE LEVEL HAS BEEN SIGNIFICANTLY DIFFERENT ON THE I-STAT MACHINES VERSUS CORE LAB SERUM CREATININE LEVEL.====================== MANUFACTURER RESPONSE FOR ABBOTT I-STAT MACHINE, ABOTT I-STAT MACHINE======================UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABOTT I-STAT MACHINE ABBOTT I-STAT MACHINE JJE ABBOTT POINT OF CARE ABBOT I-STAT1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * CHEMOTHERAPY