BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 22230296 · Received June 17, 2025

    Report

    Report Number
    2245578-2025-00065
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 2, 2025
    Report Date
    September 9, 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) (CARTRIDGE). APOC INCIDENT: # (B)(4) (ANALYZER). THE INVESTIGATION WAS COMPLETED ON 04-SEP-2025. THE CUSTOMER REPORTED THAT ANALYZER S/N (B)(6) WAS GIVING DISCREPANT POTASSIUM (K) PATIENT RESULTS USING I-STAT CHEM8+ CARTRIDGE LOT H25042A, WHEN COMPARED TO RESULTS OBTAINED FROM AN ED LABORATORY ANALYZER. THE CUSTOMER ALSO MENTIONED THAT THE I-STAT ANALYZER TEST RESULTS WERE TOO HIGH. FOR INCIDENT (B)(4): FAILURE ANALYSIS COULD NOT BE PERFORMED AS ANALYZER S/N (B)(6) HAS NOT BEEN RETURNED TO FLEX. A ROCKETWARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). ANALYZER TO BE INVESTIGATED SEPARATELY IN INCIDENT# (B)(4). PRODUCT#: 04P75-41, DESCRIPTION: I-STAT 1, SN: (B)(6). 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 15-JUL-2025. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED 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 H25042A.

    Description of Event or Problem · 0

    ON (B)(6) 2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE AND I-STAT 1 ANALYZER SN (B)(6) THAT YIELDED A DISCREPANT POTASSIUM RESULT ON A 64-YEAR-OLD FEMALE PATIENT IN FOR DIALYSIS. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. I-STAT SN (B)(6) IS BEING REPLACED AND WILL BE INVESTIGATED SEPARATELY. METHOD DATE: COLLECTED TESTED: K (MMOL/L): SAMPLE: I-STAT ON (B)(6) 2025 , 13:45 , 13:45 , 6.6 , A, I-STAT ON (B)(6) 2025, 13:49 , 13:49 , 7.3 , B, ED LAB ON (B)(6) 2025, NI , NI , NORMAL, C. ACUTUAL RESULT NOT PROVIDED. 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.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448327 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA H25042A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female