BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG4+ CARTRIDGE

    MDR report key: 20344884 · Received October 1, 2024

    Report

    Report Number
    2245578-2024-00180
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 24, 2024
    Report Date
    April 11, 2025
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    PMA / PMN Number
    K200492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 25-NOV-2024. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV AN, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. A DEFICIENCY WAS PREVIOUSLY IDENTIFIED FOR THIS CARTRIDGE LOT, WHICH IS UNRELATED TO THE CUSTOMER'S COMPLAINT, AND IS BEING INVESTIGATED IN QUALITY RECORD (QR) (B)(4).

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: #(B)(4). FDA INQUIRY: CURRENTLY, THE REPORT (#2245578-2024-00180) LISTS PROCODE: KHP. HOWEVER, THIS REPORT IS FOR PCO2 TEST AND THE PROCODE NEEDS TO BE CORRECTED FROM KHP TO CHL. CORRECTION (SECTION D2B): CHANGE FROM KHP TO CHL.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). FDA INQUIRY: CURRENTLY, THE REPORT (#2245578-2024-00180) LISTS PROCODE: KHP. HOWEVER, THIS REPORT IS FOR PCO2 TEST AND THE PROCODE NEEDS TO BE CORRECTED FROM KHP TO CHL. CORRECTION (SECTION D2B): CHANGE FROM KHP TO CHL.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    COMMUNCATION RECIEVED ON 20-MAR-2025. SEE H10 FOR CORRECTION AND ADDITIONAL DETAILS REQUESTED.

    Description of Event or Problem · 0

    COMMUNICATION RECEIVED ON 26-FEB-2025. SEE H10 FOR CORRECTION AND ADDITIONAL DETAILS REQUESTED.

    Description of Event or Problem · 0

    ON (B)(6)2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT PC02 RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED PCO2 SAMPLE I-STAT (B)(6) 2024 20:24 20:24 16 MMHG A RAPID POINT 500 NI 21:13 21:16 39 MMHG B THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915166 I-STAT CG4+ CARTRIDGE CG4+ CARTRIDGE CHL ABBOTT POINT OF CARE NA M24169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown