BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT G3+ CARTRIDGE

    MDR report key: 3596679 · Received January 29, 2014

    Report

    Report Number
    2245578-2014-00005
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    PMA / PMN Number
    K940918
    Removal / Correction Number
    APOC2014-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. (B)(4).

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THAT I-STAT® G3+ CARTRIDGES FROM CARTRIDGE LOT N13183 HAVE THE POTENTIAL TO EXHIBIT INCORRECTLY ELEVATED PCO2 AND DEPRESSED PH RESULTS. ABBOTT POINT OF CARE HAS DETERMINED THAT INDIVIDUAL DATA POINTS ASSOCIATED WITH THIS CARTRIDGE LOT HAVE THE POTENTIAL TO EXHIBIT INCORRECTLY ELEVATED PCO2 AND DEPRESSED PH RESULTS. INTERNAL STUDIES HAVE DEMONSTRATED THAT PCO2 RESULTS CAN BE ELEVATED BY 10 TO 25 MMHG, PH RESULTS CAN BE DEPRESSED BY 0.10 TO 0.15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63526 I-STAT G3+ CARTRIDGE G3+ CARTRIDGE CHL ABBOTT POINT OF CARE NA N13183

    Patients

    Seq Age Sex Outcome Treatment
    1