BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 3684452 · Received March 18, 2014

    Report

    Report Number
    2245578-2014-00012
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 25, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 03/26/2014. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. RETAIN AND CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT A PATIENT SAMPLE. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. DATE DRAW TIME RESULT TIME K NA ICA (B)(6) 2014 10:30AM 10:49AM >9.0 133 3.5 (B)(6) 2014 - 11:24AM 3.8 144 4.7 SAME SAMPLE WAS REPEATED. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THERE WERE NO INJURIES REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159468 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA J13303

    Patients

    Seq Age Sex Outcome Treatment
    1