BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 10044764 · Received May 11, 2020

    Report

    Report Number
    2939693-2020-00018
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    January 15, 2020
    Report Date
    May 11, 2020
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, ABAXIS WAS CONTACTED BY A CUSTOMER LAB THAT THEY ARE SEEING LOW POTASSIUM (K+) PATIENT RESULTS USING THEIR PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(4). CUSTOMER ALSO INDICATED THERE WAS A TEMPERATURE ERROR OBSERVED ON THE ANALYZER PRIOR TO RECEIVING THE LOW K+ RESULTS AND THAT THE ANALYZER FILTER WAS DIRTY WITH WHITE LOOKING DUST. WHEN ASKED BY ABAXIS TECHNICAL SUPPORT IF THERE WAS A HUMIDIFIER NEARBY THE ANALYZER, THE CUSTOMER RESPONDED THERE WAS. ABAXIS TECHNICAL SUPPORT LET CUSTOMER KNOW THAT THIS WOULD BE DUE TO THE HUMIDIFIER NEARBY AND TO RETURN INSTRUMENT BACK TO ABAXIS FOR SERVICE. AFTER LAB NOTICED THE ISSUE ON MULTIPLE PATIENT RESULTS, THEY RAN THEIR OWN STUDY AND RECEIVED THE FOLLOWING RESULTS: K+ 3.7 (3.6-5.1) MMOL/L VS OUTSIDE LAB 4.5 MMOL/L, K+ 3.0* (3.6-5.1) MMOL/L VS OUTSIDE LAB 4.0 MMOL/L, K+ 3.6* (3.6-5.1) MMOL/L VS OUTSIDE LAB 4.7 MMOL/L. THE FIRST FEW PATIENTS WERE TREATED SINCE CLINIC THOUGHT THEY WERE TRULY LOW BUT NO PATIENT IMPACT WAS REPORTED BY THE CLINIC BECAUSE OF TREATMENT. INVESTIGATION INTO THE RETURNED ANALYZER CONFIRMED LOW K+ READING USING CONTROL LOTS. HUMIDITY RESIDUE WAS EVIDENT IN ROTOR CHAMBER OF ANALLYZER AND OTHER SUB-ASSAY PC BOARDS DUE TO THE HUMIDIFIER KEPT BY CUSTOMER NEARBY ANALYZER. A LOOK INTO EXTRACTED FILES FROM ANALYZER ALSO SHOWED A SUDDEN DROP IN FLASH THROUGHPUT AND AN INCREASE IN TEMPERATURE. LAMP FAILED FOR LOW ADC. ABAXIS' REPAIRS TEAM CLEANED ALL HUMIDITY RESIDUE AND OPTICS ASSAY AS WELL AS REPLACED LAMP. REPAIRED ANALYZER PASSED POST EVALUATION TESTING AND RECOVERED ALL ANALYTES IN RANGE. REPAIRED ANALYZER WAS RETURNED TO CUSTOMER AND CUSTOMER CONFIRMED NO ADDITIONAL ISSUES SINCE RECEIPT.

    Description of Event or Problem · 1

    LOW POTASSIUM (K+) PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505508 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO ANALYZER JJG ABAXIS, INC. 1100-0000

    Patients

    Seq Age Sex Outcome Treatment
    1