BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 25162629 · Received May 13, 2026

    Report

    Report Number
    2245578-2026-00109
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CEM
    UDI-DI
    10054749000163
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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.

    Description of Event or Problem · 0

    ON 30-APR-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION NOR DETAILS SURROUNDING THE EVENT AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: DATE: COLLECTED: TESTED: HCO3: BE, ECF: K: HCT: HB: SAMPLE: LAB ALINITY, (B)(6) 2026, 05:43, 05:43, 21 MMOL/L, NI, 4.0 MMOL/L, 29.9%, 9.6 G/DL A VEN; I-STAT, (B)(6) 2026, 06:55, 06:55, 14.6 MMOL/L, -10 MMOL/L, 2.7 MMOL/L, 20 %, 6.8 G/DL, B ART; I-STAT, (B)(6) 2026, 07:20, 07:20, 12.1 MMOL/L, -13 MMOL/L, 2.4 MMOL/L, <15%, <> C ART; I-STAT, (B)(6) 2026, 08:11, 08:11, 22.8 MMOL/L, -2 MMOL/L, 3.6 MMOL/L, 26%, 8.8 G/DL, D ART. 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
    459824 I-STAT CG8+ CARTRIDGE CG8+ CARTRIDGE CEM ABBOTT POINT OF CARE NA W26049 10054749000163

    Patients

    Seq Age Sex Outcome Treatment
    1