BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    MDR report key: 10347603 · Received July 30, 2020

    Report

    Report Number
    2939693-2020-00080
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    September 12, 2019
    Report Date
    July 24, 2020
    Manufacturer
    ABAXIS, INC.
    Product Code
    CHJ
    UDI-DI
    EABA1100000001
    PMA / PMN Number
    K010670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12-SEP-2020, ABAXIS WAS CONTACTED BY THE CUSTOMER LAB STATING THAT A LAB RESULT YIELDED AN UNEXPECTED HIGH CHLORIDE RESULT WHEN COMPARED TO SODIUM RESULTS. THE RECOMMENDED REFERENCE RANGE FOR THE PICCOLO SYSTEM IS 98-108MMOL/L. THE CUSTOMER SENT THE DATA FOR ABAXIS FOR REVIEW. THE LAB RAN CONTROLS ON 10-SEP-2020 AND BOTH LEVELS WERE IN RANGE, INDICATING THAT THE PICCOLO SYSTEM WAS PERFORMING AS EXPECTED. A REVIEW OF THE BATCH RECORD SHOWED THAT THE LOT WAS REVIEWED DUE TO A SHIFT IN SODIUM VALUES AND WAS SPLIT INTO TWO LOTS. BOTH SUB-LOTS MET ALL RELEASE CRITERIA. ROTORS FROM THIS LOT WERE INVESTIGATED FROM ANOTHER CALL (M924310) AND THE HIGH CHLORIDE ISSUE COULD NOT BE DUPLICATED. THE HIGH OF 107MMOL/L IS THE LAB'S SET HIGH END OF THE RANGE. THE RESULT OF 108MMOL/L FALLS WITHIN THE RECOMMENDED PICCOLO REFERENCE RANGE. A REVIEW OF THE COMPLAINT DATA SHOWED THAT THERE WERE A TOTAL OF 40 ROTORS FROM THIS LOT WITH ALLEGED HIGH CHLORIDE RESULTS OUT (B)(4) ROTORS SHIPPED FOR A COMPLAINT RATE OF 0.37%. THE CUSTOMER LAB HAS NOT EXPERIENCED ANY NEW HIGH CHLORIDE RESULTS THAT WERE NOT EXPECTED. THERE WAS NO REPORTED PATIENT IMPACT AND NO OBSERVED TREND. THE PICCOLO DEVICE REMAINS AT THE CUSTOMER SITE. 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 LAB REPORTED THAT THE DEVICE YIELDED AN UNEXPECTED HIGH CHLORIDE RESULT WHEN COMPARED TO SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807176 PICCOLO COMPREHENSIVE METABOLIC PANEL PICCOLO METABOLIC PANEL CHJ ABAXIS, INC. 9214AB1 EABA1100000001

    Patients

    Seq Age Sex Outcome Treatment
    1