BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO XPRESS BLOOD CHEMISTRY ANALYZER

    MDR report key: 2343564 · Received November 15, 2011

    Report

    Report Number
    2939693-2011-00002
    Event Type
    Injury
    Date Received
    November 15, 2011
    Date of Event
    October 20, 2011
    Report Date
    November 15, 2011
    Manufacturer
    ABAXIS, INC.
    Product Code
    MZV
    PMA / PMN Number
    K934592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS PRESCRIBED K+ TABLETS AND LISINOPRIL PRIOR TO INCIDENT. A FALSE HIGH POTASSIUM (K+) WAS REPORTED USING THE PICCOLO XPRESS CHEMISTRY ANALYSERS (SERIAL NUMBER (B)(4)) WITH COMPREHENSIVE METABOLIC PANEL (CMP) LOT 1124BC5. MD DIRECTED PT TO DISCONTINUE TAKING K+ TABLETS AND APPROX ONE WEEK LATER, PT WAS TESTED AGAIN WITH THE PICCOLO WITH SAME LOT OF CMP, AND K+ RESULTS REMAINED HIGH. MD DIRECTED PT TO STOP EATING BANANAS AND WAS TESTED ONE MORE TIME A WEEK LATER WITH PICCOLO AND SAME LOT OF CMP, AND RESULTS WERE STILL HIGH. MD DIRECTED PT TO TAKE KAYEXALATE (TO LOWER K+) AND TO DISCONTINUE LISINOPRIL. PT WAS TESTED ONE MORE TIME A DAY LATER WITH PICCOLO AND A DIFFERENT LOT CMP #1204BC5, RESULTS WERE STILL HIGH FOR K+. MD RECOMMENDED PT TO TAKE ANOTHER DOSE OF KAYEXALATE. (UNSURE IF PT TOOK THE RECOMMENDED SECOND DOSE). PT WAS TESTED SAME DAY IN THE HOSPITAL AND RESULTS WERE WITHIN NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICCOLO XPRESS BLOOD CHEMISTRY ANALYZER PICCOLO XPRESS BLOOD CHEMISTRY ANALYZER MZV ABAXIS, INC. 1100-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other