BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 685621 · Received March 6, 2006

    Report

    Report Number
    2245578-2006-00003
    Event Type
    Malfunction
    Date Received
    March 6, 2006
    Date of Event
    February 6, 2006
    Report Date
    March 6, 2006
    Manufacturer
    I-STAT CORP.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED IN 2/2006 THAT A PATIENT SAMPLE GENERATED AN I-STAT HEMATOCRIT OF 25% PCV AND THE LABORATORY RESULT WAS 29% PCV. A SPUN HEMATOCRIT WAS PERFORMED ON THE SAMPLE WHICH GENERATED A RESULT OF 29% PCV. NO TREATMENT WAS GIVEN BASED ON THE HEMATOCRIT RESULT OF 25% PCV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EG7+ CARTRIDGE IVD MMI I-STAT CORP. NA U05249A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR