BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 12218212 · Received July 23, 2021

    Report

    Report Number
    2939693-2021-00006
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    June 23, 2021
    Report Date
    September 7, 2021
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    UDI-DI
    EABA11000000E1
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF THE INVESTIGATION CONCLUDED THAT THE FAN AND OPTICS ASSEMBLY CONTRIBUTED TO THE CUSTOMER'S REPORTED PROBLEM. DURING EVALUATION OF THE DEVICE, THE DEVICE CONTINUOUSLY DISPLAYED "ANALYZER TOO HOT" MESSAGES AS WELL AS 404F TEMPERATURE ERRORS. MULTIPLE ANALYTES WERE FOUND TO BE OUT OF RANGE, WITH K+ BEING NEARLY DOUBLE TARGET VALUE. THE FAN AND FILTER WERE REPLACED AND BI-LEVEL CONTROLS WERE RE-RAN. ALL ANALYTES WERE AT AN ACCEPTABLE LEVEL AND K+ WAS NEAR TARGET VALUE. THE LAMP AND OPTICS ASSEMBLY PASSED ON ALL TESTERS. THE DEVICE WAS CALIBRATED, TESTED, AND SHIPPED BACK TO THE CUSTOMER SITE. NO FURTHER ACTIONS WERE REQUIRED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021, ABAXIS RECEIVED A CALL FROM THE CUSTOMER LAB STATING THAT THE DEVICE YIELDED UNEXPECTED DISCREPANT POTASSIUM PATIENT RESULTS WHEN COMPARED TO ANOTHER DEVICE. THE PATIENT WAS DRAWN WITH THE PICCOLO AND THE RESULTS WERE LOW AND OUT OF RANGE. THE PATIENT WAS TREATED APPROXIMATELY 3 HOURS POST THE INITIAL RESULT, BEING INFUSED WITH KCL 20MEQ/10ML OVER A 120 MINUTE DURATION. THE PATIENT WAS THEN REDRAWN APPROXIMATELY ONE HOUR OF THE INITIAL TREATMENT AND TESTED ON THE ROCHE COBAS AND THE RESULTS WERE WITHIN RANGE. APPROXIMATELY AN HOUR LATER, THE PATIENT WAS INFUSED WITH KCL 10MEQ/10ML OVER A 60 MINUTE PERIOD. THE CUSTOMER SENT THE DEVICE BACK IN FOR EVALUATION AND WAS SENT A LOANER DEVICE. A FOLLOW UP WITH THE DOCTOR CONFIRMED THAT THE PATIENT TREATMENT BASED ON THE INITIAL RESULT HAD NO POTENTIAL HARM TO THE PATIENT. THE DEVICE HAS BEEN RECEIVED AND IS PENDING COMPLETION OF AN EVALUATION. ALL ADDITIONAL INFORMATION WILL BE SENT IN A FOLLOW UP REPORT WHEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER LAB REPORTED THAT THE DEVICE YIELDED DISCREPANT POTASSIUM PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118404 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO XPRESS CHEMISTRY ANALYZER JJG ABAXIS, INC. EABA11000000E1

    Patients

    Seq Age Sex Outcome Treatment
    1