BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 3319797 · Received August 30, 2013

    Report

    Report Number
    2245578-2013-00094
    Event Type
    Malfunction
    Date Received
    August 30, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 9, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 10/01/2013. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED POTASSIUM RESULT OF <2 VERSES THE LAB ON A (B)(6) FEMALE PATIENT WITH DIAGNOSIS OF MI, PE, RESPIRATORY FAILURE, AND SEPSIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. DATE DRAW-TIME TEST-TIME K RESULT METHOD SAMPLE(B)(6) 2013 07:04 07:16 <2 I-STAT A(B)(6) 2013 07:04 07:16 4.3 VISTA B (DIFFERENT SAMPLE, SAME DRAW TIME)(B)(6) 2013 07:25 07:33 4.3 I-STAT BTHE SITE STATES THAT THEY ARE CURRENTLY USING GREINER BIO-ONE VACUETTE TUBES AND HAVE SUSPECTED INCONSISTENCIES IN RESULTS BUT NOT CONFIRMED. THE SITE IS CURRENTLY TESTING AND EVALUATING BD LITHIUM HEPARIN TUBES AND IS PLANNING TO SWITCH TO THESE TUBES FOR SAMPLING BY THE END OF 2013.THERE WERE NO INJURIES REPORTED WITH THIS EVENT. THE PATIENT WAS ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430120 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA J13072

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR