BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO METLYTE 8 PANEL

    MDR report key: 10347600 · Received July 30, 2020

    Report

    Report Number
    2939693-2020-00086
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    January 25, 2019
    Report Date
    July 24, 2020
    Manufacturer
    ABAXIS, INC.
    Product Code
    CEM
    UDI-DI
    EABA1100000001
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019, ABAXIS RECEIVED A CALL FROM THE CUSTOMER LAB STATING THAT THE DEVICE YIELDED UNEXPECTED LOW POTASSIUM RESULTS COMPARED TO ANOTHER SAMPLE DRAWN FROM PATIENT. THERE WAS NO REPORTED PATIENT IMPACT. THE LAB PREVIOUSLY RAN CONTROLS AND BOTH LEVELS WERE WITHIN RANGE. THE LAB TREATED THE PATIENT WITH A POTASSIUM IV DRIP WITHOUT CONFIRMING THE RESULT. THE LAB REDREW THE PATIENT AFTER APPROXIMATELY ONE HOUR OF TREATMENT AND THE POTASSIUM RESULT WAS AT THE LOW END OF THE NORMAL RANGE INDICATING THAT THE LOW POTASSIUM RESULT WAS CORRECT. THE LAB RAN CONTROLS ON THE LOT AGAIN APPROXIMATELY THREE MONTHS LATER AND BOTH LEVELS WERE WITHIN RANGE NEAR THE MEAN VALUE. THE LAB RECEIVED A REPLACEMENT PICCOLO ANALYZER AND HAS NOT EXPERIENCED ANY FURTHER UNEXPECTED POTASSIUM RESULTS SINCE. NO FURTHER ACTIONS WERE REQUIRED. THIS MDR IS BEING SUBMITTED AS A RESULT OF A THREE (3) YEAR RETROSPECTIVE REVIEW OF CLOSED COMPLAINTS ABAXIS PERFORMED AS PART OF ITS COMMITMENT TO CORRECT THE FDA-483 OBSERVATIONS RECEIVED ON AUGUST 22, 2019.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE YIELDED UNEXPECTED LOW POTASSIUM RESULTS COMPARED TO ANOTHER SAMPLE DRAWN FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807174 PICCOLO METLYTE 8 PANEL METLYTE PANEL CEM ABAXIS, INC. 8191HA3 EABA1100000001

    Patients

    Seq Age Sex Outcome Treatment
    1