BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT G3+ CARTRIDGE

    MDR report key: 1839895 · Received September 17, 2010

    Report

    Report Number
    2245578-2010-00121
    Event Type
    Other
    Date Received
    September 17, 2010
    Date of Event
    April 28, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    JJE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT G3+ CARTRIDGE YIELDED A PCO2 RESULT OF 64.1 MMHG, SAMPLE COLLECTED 17:34, REC'D 17:39 ON (B)(4) 2010. NEW SAMPLE TESTED USING I-STAT G3+ CARTRIDGE YIELDED A PCO2 RESULT OF 81.9 MMHG, SAMPLE COLLECTED 19:46, REC'D 20:47 ON (B)(4) 2010. AN UMBILICAL ARTERIAL CATHETER (UAC) VENT WAS PLACED IN PT BASED ON I-STAT RESULTS. LOT NUMBER NOT PROVIDED BY THE CUSTOMER, A SEARCH WAS CONDUCTED OF LOTS REC'D BY THE CUSTOMER: R09283, EXPIRATION: 05/28/2010; P09315, EXPIRATION: 06/28/2010; P09346, EXPIRATION: 07/28/2010; T09352, EXPIRATION: 08/14/2010, P10075, EXPIRATION: 10/28/2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT G3+ CARTRIDGE G3+ CARTRIDGE JJE ABBOTT POINT OF CARE CANADA LTD. P09244

    Patients

    Seq Age Sex Outcome Treatment
    1 Other