BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 16938190 · Received May 16, 2023

    Report

    Report Number
    2245578-2023-00060
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 8, 2023
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000163
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 07-JUN-2023. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. DUE TO THE EXPIRATION OF CG8+ CARTRIDGE LOT W22265 (22-MAY-2023), RETAINED TESTING COULD NOT BE PERFORMED. NO DEFICIENCY HAS BEEN DETERMINED FOR CG8+ CARTRIDGE LOT W22265.

    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 (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT SODIUM AND POTASSIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD DATE TESTED TEST RESULTS SAMPLE I-STAT , (B)(6) 2023, 07:56, NA 114MMOL/L A. LAB, (B)(6) 2023, NI NA 139.45MMOL/L NI. I-STAT, (B)(6) 2023, 07:56 K 6.2MMOL/L A. LAB, (B)(6) 2023, NI K 4.35MMOL/L NI. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183943 I-STAT CG8+ CARTRIDGE CG8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA W22265 10054749000163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown