BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 6266591 · Received January 20, 2017

    Report

    Report Number
    2245578-2017-00004
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    January 8, 2017
    Report Date
    February 10, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 01/31/2017. RETAIN PRODUCT AND CUSTOMER RETURNS WERE TESTED AND THE CUSTOMER COMPLAINT WAS NOT REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT SODIUM, CHLORIDE & HEMATOCRIT ON A (B)(6) YEAR OLD FEMALE PATIENT PRESENTED IN THE ER WITH SHORTNESS OF BREATH. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. CUSTOMER STATES THAT PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: SAMPLE: TIME: NA: CI: HCT: (B)(6) 2017, A, 15:23, 110, >140, 31%. (B)(6) 2017, A, 15:29, 143, >105, 40%. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50525 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H16253A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR