BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 23746610 · Received December 8, 2025

    Report

    Report Number
    2939693-2025-00007
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 10, 2025
    Report Date
    March 26, 2026
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    UDI-DI
    EABA110000001
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS DISCHARGED TO FOLLOW UP WITH THEIR PROVIDER. THE END USER COULD NOT PROVIDE DETAILS REGARDING THE TREATMENT ADMINISTERED AND ITS TIMING. THEY WERE NOT DIRECTLY INVOLVED WITH THE PATIENT AND DO NOT HAVE ACCESS TO THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. IT IS UNKNOWN WHETHER THE END USER WILL RETURN THEIR INSTRUMENT FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING, THE TECHNICAL SERVICE REPRESENTATIVE SENT NEW PIPETTES TO THE CUSTOMER TO ENSURE THAT CALIBRATED PIPETTES ARE BEING USED DURING SAMPLE HANDLING. THE ANALYZER WAS RETURNED FOR INVESTIGATION WITHOUT THE COMPACT FLASH (CF) CARD. AS A RESULT, INSTRUMENT DETAILS AND CONFIGURATION DATA WERE UNAVAILABLE, AND A PRE-EVALUATION CHEMISTRY TEST COULD NOT BE DONE DUE TO THE ABSENCE OF BASELINE RESULTS FOR COMPARISON. A NEW CF CARD WAS INSTALLED TO VERIFY BASIC MECHANICAL OPERATION. THE OPTICS ASSEMBLY FAILED DUE TO CROSSTALK AT THE 550 NM FILTER CHANNEL, A CONDITION THAT CAN BE ATTRIBUTED TO INCONSISTENT CHEMISTRY RESULTS. THE MAIN OPTICS ASSEMBLY WAS REPLACED, AND THE ANALYZER WAS CLEANED. ALL REQUIRED FUNCTIONAL TESTING WAS PERFORMED. THE ANALYZER PASSED BI-LEVEL AND VERIFICATION SAMPLE CHEMISTRY TESTS POST REPAIRS. THE FAILED OPTICS ASSEMBLY AND CONTAMINATION (BLOOD SPATTER IN THE DISC DRAWER) LIKELY CONTRIBUTED TO THE INCONSISTENT CHEMISTRY. LOW POTASSIUM RESULTS MAY BE DUE TO IMPROPER SAMPLE HANDLING, A CONTAMINATED ANALYZER, OR UNKNOWN INTERFERENCES IN THE WHOLE BLOOD SAMPLE. ADDITIONALLY, THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THE CUSTOMER HAS RECEIVED THE ANALYZER BACK WITH NO FURTHER CONCERNS. A REVIEW OF THE BATCH RECORD SHOWED NO UNACCEPTABLE POTASSIUM READINGS DURING MANUFACTURING, AND THE PICCOLO BMP PANEL 5235AA3 MET ALL RELEASE CRITERIA WITH NO DEVIATIONS. A REVIEW OF THE COMPLAINT DATA SHOWED THAT 5 ROTORS FROM THIS LOT, ALL FROM THIS CLINIC, WERE REPORTED FOR LOW POTASSIUM OUT OF (B)(4) ROTORS SHIPPED, FOR A COMPLAINT RATE OF (B)(4). THERE HAS BEEN NO OBSERVED TREND IN LOW POTASSIUM OVER THE LAST 12 MONTHS ENDING IN NOV 2025, AND NO REPORTED PATIENT IMPACT CONTRIBUTING OR RESULTING IN INJURY OR HOSPITALIZATION.

    Description of Event or Problem · 0

    10NOV2025: ZOETIS UNION CITY TECHNICAL SUPPORT RECEIVED A CALL FROM A HEALTHCARE PROFESSIONAL REPORTING AN UNEXPECTED LOW POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER, SERIAL NUMBER (B)(6), AND THE PICCOLO BASIC METABOLIC PANEL (BMP), LOTS 5235AA3,5182AB1, AND PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP) LOT 5301BC0.THE PATIENT WAS TREATED. THE CUSTOMER EXPRESSED CONCERN ABOUT THE ACCURACY OF THE PICCOLO XPRESS ANALYZER SN (B)(6) AFTER COMPARING POTASSIUM (K+) RESULTS FROM THE SAME SAMPLE RUN ON THEIR SECOND PICCOLO XPRESS ANALYZER (B)(6) USING THE PICCOLO CMP PANEL, LOT 5301BC01. THE EXPECTATION WAS THAT BOTH THE BMP PANEL AND THE COMPARISON CMP PANEL WOULD YIELD SIMILAR POTASSIUM RESULTS. CHEM HIGH/LOW: LOW ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2754971 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO XPRESS CHEMISTRY ANALYZER JJG ABAXIS, INC. EABA110000001

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female