BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 22961897 · Received September 4, 2025

    Report

    Report Number
    2245578-2025-00107
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    CHL
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 22-SEP-2025. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AO, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR EG7+ CARTRIDGE LOT N25039.

    Description of Event or Problem · 0

    ON (B)(6) 2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT PO2 RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TEST DATE: (B)(6) 2025. METHOD, COLLECTED, TESTED PH, PCO2, PO2, BEECF, HCO3, TCO2, SO2, NA, K, ICA, HCT, HB SAMPLE. I-STAT, 21:00, 21:03, 6.881 >130.0, 243, 130, 5.5, 1.11, 34, 11.6, 1. I-STAT, 22:32, 22:32, 6.985 >130.0, 240, 137, 4.7 1.05, 32, 10.9, 2. TEST DATE: (B)(6) 2025. METHOD, COLLECTED, TESTED, PH, PCO2, PO2, BEECF, HCO3, TCO2, SO2, NA, K, ICA, HCT, HB CL, SBC SAMPLE. I-STAT, 09:15, 09:18, 7.134 >130, 12, 149, 4.0, 0.93, 31, 10.5, 3. HDC-LYT, 12:15, 12:25, 7.109, 123, 65.47, 12.55, 42.26, 46.22, 90.80, 168, 5.42, 3.65, 37.3, 12.43, 96.4, 32.42, 4. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON 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
    1292634 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE CHL ABBOTT POINT OF CARE INC. NA N25039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown