BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 22435527 · Received July 8, 2025

    Report

    Report Number
    2245578-2025-00075
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    PMA / PMN Number
    K183680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: # 981707 THE INVESTIGATION WAS COMPLETED ON 06-AUG-2025. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AO, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN DETERMINED FOR CHEM8+ CARTRIDGE LOT H25079.

    Description of Event or Problem · 0

    ON (B)(6) 2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT CREATININE RESULT ON AN 78-YEAR-OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: TESTED NA K: GLU HCT SAMPLE: I-STAT (B)(6) 2025, 10:23 110 >9.0, 102, 21 WB, I-STAT (B)(6) 2025 , 10:37 112 >9.0, 97 , <15 WB, ROCHE (B)(6) 2025, 12:31 141 4.7, 111, 34.7 NI, I-STAT (B)(6) 2025 , 15:35 138 4.5 , 110, <15 PLAMA. 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
    341508 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA H25079

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male