BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO XPRESS BLOOD CHEMISTRY ANALYZER

    MDR report key: 2471904 · Received February 27, 2012

    Report

    Report Number
    2939693-2012-00001
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 24, 2012
    Manufacturer
    ABAXIS, INC.
    Product Code
    MZV
    PMA / PMN Number
    K934592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: SINCE THERE WAS NO PROBLEM FOUND WITH THE ANALYZER AND THERE HAVE BEEN NO OTHER COMPLAINTS FOR HIGH CREATININE, EITHER FROM THIS CLINIC OR FROM THE REAGENT DISC LOT, THE CAUSE OF THE SINGLE ERRONEOUS HIGH CREATININE RESULT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A FALSE HIGH CREATININE (CRE) RESULT WAS REPORTED ON (B)(6) 2012 USING THE PICCOLO XPRESS BLOOD CHEMISTRY ANALYZER, SERIAL NUMBER (B)(4), WITH COMPREHENSIVE METABOLIC PANEL (CMP), LOT # 1482BC3. MD SENT PT FOR AN ULTRASOUND EXAMINATION AND PRESCRIBED NEW DIABETES AND BLOOD PRESSURE MEDICATIONS. THE SAME SAMPLE WAS SENT TO AN OUTSIDE LAB WHICH REPORTED A NORMAL CRE RESULT ON (B)(6) 2012. MD REVIEWED THE OUTSIDE LAB RESULTS ON (B)(6) 2012 AND THEN ADVISED THE PT TO DISCONTINUE USE OF THE NEW MEDICATIONS. PT WAS ADVISED TO RETURN TO PREVIOUS DIABETES MEDICATION. MD DECIDED TO CONTINUE WITH THE NEW BLOOD PRESSURE MEDICATION. ACCORDING TO THE PROVIDER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AND IS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other