BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 2112650 · Received April 28, 2011

    Report

    Report Number
    2245578-2011-00055
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING DISCREPANT RESULTS BETWEEN THE I-STAT AND OLYMPUS FOR POTASSIUM AND THE I-STAT AND BECKMAN COULTER FOR HEMOGLOBIN. AT 7:07:19AM, I-STAT HEMOGLOBIN 6.5, I-STAT POTASSIUM 2.9. BECKMAN HEMOGLOBIN 8.8, OLYMPUS POTASSIUM 3.8. AT 12:20PM, A SECOND SAMPLE WAS DRAWN WITH THE FOLLOWING RESULTS: I-STAT HEMOGLOBIN 10.9, I-STAT POTASSIUM 4.9. BECKMAN HEMOGLOBIN 10.9, OLYMPUS POTASSIUM 5.2. BASED ON THE INFO AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THE EVENT. THE INITIAL LOW HGB RESULTS GENERATED BY THE I-STAT ANALYZER WERE NOT REPORTED OUTSIDE THE LAB. BASED ON THE INFO PROVIDED, THE TRANSFUSION DECISION WAS BASED ON THE BECKMAN ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE CEM ABBOTT POINT OF CARE N10335

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR