BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 6+ CARTRIDGE

    MDR report key: 2843622 · Received October 25, 2012

    Report

    Report Number
    2245578-2012-00393
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ABBOTT POINT OF CARE, INC.
    Product Code
    JGS
    PMA / PMN Number
    K912387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 (B)(4) 2012. NO DEFICIENCY WAS IDENTIFIED AND THE CARTRIDGES ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT 6+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF >9.0 AND A SODIUM RESULT OF 118. THE CUSTOMER STATES THAT THE OPERATOR WHO PERFORMED THE TEST IS NEW AND WAS TESTING AN EDTA TUBE FOR CBC ON THE COULTER AT THE SAME TIME THAT TESTING WAS DONE ON THE I-STAT. CUSTOMER SUSPECTS POSSIBLE SAMPLE MISHANDLING, THOUGH NOT CONFIRMED. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME APOC DOES NOT SUSPECT A PRODUCT MALFUNCTION EXISTS. THE INCREASED POTASSIUM RESULT OF >9.0 ON I-STAT STRONGLY SUGGESTS THAT HEMOLYSIS OR THE USE OF EDTA ARE THE POTENTIAL CAUSES HOWEVER, NOT CONFIRMED AT THIS TIME. THE INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT 6+ CARTRIDGE 6+ CARTRIDGE JGS ABBOTT POINT OF CARE, INC. NA H12202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Congenital Anomaly