BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 20557368 · Received October 29, 2024

    Report

    Report Number
    2245578-2024-00201
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 20, 2024
    Report Date
    December 3, 2024
    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). THE INVESTIGATION WAS COMPLETED ON 25-NOV-2024. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING FOR LOT H24172 MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV AN, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR CHEM8+ CARTRIDGE LOT H24172.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # 964929 APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    ON 25-OCT-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT HEMATOCRIT RESULT ON PATIENT. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED NA CREA SAMPLE I-STAT 20-OCT-2024 09:57 09:57 124 MEQ/L 8.2 MG/DL A I-STAT 20-OCT-2024 11:04 11:04 124 MEQ/L 8.0 MG/DL B VS2 20-OCT-2024 NI 11:09 148 MMOL/L 4.1 MG/DL NI . 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
    319074 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA H24172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown