BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 799289 · Received December 21, 2006

    Report

    Report Number
    2245578-2006-00031
    Event Type
    Other
    Date Received
    December 21, 2006
    Date of Event
    December 1, 2006
    Report Date
    December 21, 2006
    Manufacturer
    ABBOTT POINT OF CARE, INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT A PT HAD BEEN TRANSFUSED BASED ON A HEMOGLOBIN RESULT OF 7 G/DL FROM I-STAT EG7+ CARTRIDGE. THE SAME SAMPLE WAS REPEATED ON THE I-STAT SYSTEM USING AN I-STAT EG7+ CARTRIDGE LOT U06269A AND A RESULT OF 8 G/DL WAS OBTAINED. A REPEAT SAMPLE WAS DRAWN AND SENT TO THE LABORATORY TO BE RUN ON ANOTHER METHOD. THE LABORATORY METHOD GAVE A HEMOGLOBIN RESULT OF 13 G/DL. NO ADDITIONAL INFO IS AVAILABLE FROM THE CUSTOMER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EG7+ CARTRIDGE IVD MMI ABBOTT POINT OF CARE, INC. NA U06269A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other