BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 24306917 · Received February 10, 2026

    Report

    Report Number
    2245578-2026-00027
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 14, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    PMA / PMN Number
    K183680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 09-APR-2026. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING OF CHEM8+ LOT H25257 AND RETAINED AND RETURNED CARTRIDGE TESTING OF CHEM8+ CARTRIDGE LOT H25301 MET THE ACCEPTANCE CRITERIA PER Q04.01.003 REV. AP, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN DETERMINED FOR CHEM8+ CARTRIDGE LOTS H25257 AND H25301.

    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

    NA.

    Description of Event or Problem · 0

    ON (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT IONIZED CALCIUM RESULT ON AN 8-MONTH-OLD FEMALE PEDIATRIC PATIENT IN THE ICU. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: DATE: COLLECTED TESTED RESULTS: SAMPLE I-STAT, (B)(6) 2026 , 19:59 , 19:59 , K: 6.8 MMOL/L, GLUC: 166 MG/DL, TCO2: 14 MMOL/L, BUN: 19 MG/DL, ICA: 0.80 MMOL/L A I-STAT, (B)(6) 2026, 20:002 , 20:05 K: 6.9 MMOL/L, GLUC: 210 MG/DL, TCO2: 12 MMOL/L, BUN: 18 MG/DL, ICA: 1.39 MMOL/L B. ROCHE (B)(6) 2026 , 20:02 , 20:30 , K: 7.9 MMOL/L, GLUC: 283 MG/DL, TCO2: 7 MMOL/L, BUN: 14 MG/DL . C. I-STAT , (B)(6) 2026, 21:15 , 21:21 , K: 6.5 MMOL/L, GLUC: 304 MG/DL. CHLORIDE: 120 MMOL/L . D ROCHE (B)(6) 2026 , 21:15, 21:31, K: 9.1 MMOL/L, GLUC: 476 MG/DL, CHLORIDE: 112 MMOL/L . E AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74953 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA H25301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown