BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 20557360 · Received October 29, 2024

    Report

    Report Number
    2245578-2024-00194
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 14, 2024
    Report Date
    December 10, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 05-DEC-2024. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING FOR LOT W24200 MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV AN, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOR SUPPRESSED RESULTS BUT THE SIZE WAS TOO LOW (<17) TO ASSESS THE RATE OF POINTS OUTSIDE TOTAL ALLOWABLE ERROR (EA). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CG8+ CARTRIDGE LOT W24200.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT #: 964094 APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    ON 15-OCT-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULTS ON A 61 YEAR-OLD FEMALE PATIENT SCREENING FOR COLON CANCER/COLONOSCOPY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS SAMPLE I-STAT1 14-OCT-24 12:56 12:56 >9.0 MMOL/L VENOUS I-STAT1 14-OCT-24 13:11 13:11 >9.0 MMOL/L VENOUS ALINITY 14-OCT-24 13:48 13:48 5.0 MMOL/L VENOUS THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. CURRENTLY THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319066 I-STAT CG8+ CARTRIDGE CG8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA W24200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown