BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM 8+N CARTRIDGE

    MDR report key: 1821079 · Received August 27, 2010

    Report

    Report Number
    2245578-2010-00117
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    CGL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT CHEM 8+ CARTRIDGE YIELDED A HEMATOCRIT RESULT OF 51%PCV, ON ANALYZER (B)(4). SEPARATE SAMPLE, THE I-STAT CHEM 8+ CARTRIDGE YIELDED A HEMOCRIT RESULT OF 19%PCV, ON ANALYZER (B)(4). SEPARATE SAMPLE, TESTED USING A LABORATORY INSTRUMENT YIELDED A HEMOCRIT RESULT OF 21.5%PCV. INITIAL I-STAT HEMATOCRIT RESULT OF 51%PCV, ON ANALYZER (B)(4), DID NOT MEET THE CLINICAL PICTURE. ADD'L INFO ON PT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM 8+N CARTRIDGE CHEM 8+ CARTRIDGE CGL ABBOTT POINT OF CARE CANADA LTD. G10146

    Patients

    Seq Age Sex Outcome Treatment
    1