BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 22437778 · Received July 8, 2025

    Report

    Report Number
    2245578-2025-00076
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 22, 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 17-JUL-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 N25093.

    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. NOR DETAILS SURROUNDING THE EVENT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: (B)(6)2025, (B)(6)2025 , (B)(6)2025, (B)(6)2025 . TIME: 10:39 , 11:13, 12:01 , 12:06, PH: 7.708 , 7.44, 7.382 , 7.092, PCO [2] (MMHG): 10.8 , 28.1, 36.8 , 47.6, PO2 (MMHG) : 183 , 167 , 23 , 173, BECF (MMOL/L) : -7, -5, -3, -15, HCO [3] (MMOL/L) : 13.1, 19.5, 21.9 , 14.5, TCO [2] (MMOL/L) : 13 , 20 , 23, 16, SO [2] (%) : 100 , 100, 40, 99, NA (MMOL/L) : 135, 136 , 134, 128, K (MMOL/L) : 4.1 , 3.1 , 3.3, >9.0, ICA (MMOL/L) : 0.87, 1.05 , 0.92, *** HCT (%): 37, 34 , 33, 33, HB VIA HCT (G/DL): 12.6 , 11.6 , 11.3, 11.2. 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.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388627 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE CHL ABBOTT POINT OF CARE INC. NA N25093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown