BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 839084 · Received April 10, 2007

    Report

    Report Number
    2245578-2007-00009
    Event Type
    Other
    Date Received
    April 10, 2007
    Date of Event
    March 12, 2007
    Report Date
    April 10, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2007, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT A PT WAS TREATED BASED ON THE FOLLOWING RESULTS FROM AN I-STAT CHEM8 CARTRIDGE LOT P06302; SODIUM 113 MEQ/L, POTASSIUM >9 MEQ/L, CHLORIDE 101 MEQ/L, TCO2 24 MEQ/L. PT WAS TREATED WITH INSULIN AND CALCIUM CHLORIDE, NA BICARB, D50, AND POSSIBLY KAYEXOLATE. A TUBE DRAWN AT THE SAME TIME (AS THE SAMPLE TESTED ON I-STAT THE SAME DAY) WAS SENT TO THE LAB AND YIELDED THE FOLLOWING RESULTS; SODIUM 123 MEQ/L, POTASSIUM 5.2 MEQ/L, CHLORIDE 88 MEQ/L, TCO2 24 MEQ/L. THERE WAS NO INJURY TO THE PT REPORTED. A POTASSIUM RESULT (LATER IN THE DAY) WAS 4.5 MEQ/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM8+ CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA P06302

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other