BEUDAMED
    FDA Adverse Event Death Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 1691816 · Received May 13, 2010

    Report

    Report Number
    2245578-2010-00028
    Event Type
    Death
    Date Received
    May 13, 2010
    Date of Event
    April 4, 2010
    Report Date
    May 12, 2010
    Manufacturer
    ABBOTT POINT OF CARE, ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    MZV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 04/14/2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE PT DIED ON (B) (6) 2010 FROM CHRONIC LYMPHOCYTIC LEUKEMIA (CLL). ON THE (B) (6) 2010, THE CUSTOMER REPORTED THE I-STAT CHEM8+ CARTRIDGE YIELDED A POTASSIUM RESULT 3.2 MMOL/L. SAME SAMPLE TESTED USING A LAB INSTRUMENT YIELDED AN POTASSIUM RESULT OF 6.7 MMOL/L, CUSTOMER STATED THE LAB SAMPLE WAS SLIGHTLY HEMOLYZED. WHITE BLOOD CELL COUNT OF THE PT WAS 300 000. THE CUSTOMER STATED, RESULTS DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFO REQUESTED FROM THE CUSTOMER REGARDING THE DEATH OF THE PT AND TREATMENT, INFO NOT PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE MZV ABBOTT POINT OF CARE, ABBOTT POINT OF CARE CANADA LTD. E10050B

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death