BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 6875350 · Received September 19, 2017

    Report

    Report Number
    2245578-2017-00301
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    August 17, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GKF
    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 # (B)(4). THE INVESTIGATION WAS COMPLETED ON 10/04/2017. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE.

    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 HEMATOCRIT RESULTS ON AN (B)(6) MALE PATIENT WHO WAS TESTED FOR POSSIBLE BLOOD LOSS; BLOOD IN STOOL FOR DAYS. THERE WAS NO ADDITIONAL PATIENT INFORMATION. THE PATIENT WAS ADMITTED ON (B)(6) 2017 AT 19:10 AND DISCHARGED AT 23:18. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THIS REPORTING IS BASED ON LIMITED INFORMATION AVAILABLE. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656762 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE GKF ABBOTT POINT OF CARE NA H17100
    656763 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE GKF ABBOTT POINT OF CARE NA H17100

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR