BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    MDR report key: 10347817 · Received July 30, 2020

    Report

    Report Number
    2939693-2020-00082
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    September 27, 2019
    Report Date
    July 24, 2020
    Manufacturer
    ABAXIS, INC.
    Product Code
    CHJ
    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 MULTIPLE UNEXPECTED HIGH CHLORIDE RESULTS ON MULTIPLE PATIENTS. THE RECOMMENDED REFERENCE RANGE FOR THE PICCOLO SYSTEM IS 98-108MMOL/L. THE LAB RAN CONTROLS ON THE LOT ON (B)(6) 2019 AND BOTH LEVELS WERE IN RANGE. A REVIEW OF THE BATCH RECORD SHOWED THAT THE LOT MET ALL RELEASE CRITERIA. THE LAB RETURNED THEIR ANALYZER FOR REPAIR. IT WAS OBSERVED THAT OCCASIONAL TEMPERATURE SPIKES ABOVE 38 DEGREES CELSIUS WERE OCCURRING. THE HEATER PLATES WERE REPLACE TO RESOLVE THE REPORTED PROBLEM. THE TEMPERATURE WAS RECALIBRATED AND THE DEVICE WAS THOROUGHLY CLEANED. THE DEVICE WAS SENT BACK TO THE CUSTOMER SITE WHERE IT REMAINS. NO FURTHER ACTIONS WERE REQUIRED. THIS CALL WAS ORIGINALLY ONE ISSUE THAT WAS SPLIT DUE TO MULTIPLE PANEL LOTS (9215AB7, 9272AB1 9242AB1). THIS MDR ADDRESSES 9242AB1. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER LAB REPORTED THAT THE DEVICE YIELDED MULTIPLE UNEXPECTED HIGH CHLORIDE RESULTS ON MULTIPLE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808198 PICCOLO COMPREHENSIVE METABOLIC PANEL PICCOLO METABOLIC PANEL CHJ ABAXIS, INC. 9242AB1

    Patients

    Seq Age Sex Outcome Treatment
    1