BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 6284059 · Received January 27, 2017

    Report

    Report Number
    2245578-2017-00006
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 18, 2017
    Report Date
    February 17, 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

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

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # 711811. THE INVESTIGATION WAS COMPLETED ON 02/09/2017. RETAIN PRODUCT WAS TESTED AND THE CUSTOMER COMPLAINT WAS NOT REPRODUCED. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

    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, POTTASSIUM & HEMATOCRIT ON A (B)(6) MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. CUSTOMER STATES THAT PRODUCT IS AVAILABLE FOR INVESTIGATION: METHOD DATE COLLECTED TESTED TCO2 NA K CI HCT: I-STAT 01/18/2017 1802 1810 31 111 3.3 >140 39; VISTA 01/18/2017 1802 1837 25 134 3.9 98 43; I-STAT 01/18/2017 1835 1835 24 134 3.8 96 47. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67163 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H16253A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR