BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 25261590 · Received May 22, 2026

    Report

    Report Number
    2939693-2026-00014
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE END USER REPORTED THAT THE INITIAL PICCOLO CMP POTASSIUM AND CHLORIDE RESULTS APPEARED ELEVATED. ABAXIS TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED TO REPEAT QC; VERIFY REAGENT/STORAGE CONDITIONS AND EXPIRATION DATES; CONFIRM ENVIRONMENTAL CONDITIONS WERE WITHIN SPECIFICATIONS; AND ENSURE PROPER SPECIMEN HANDLING. THE END USER PREFERRED NOT TO DISCLOSE DETAILS REGARDING THE PATIENT¿S INFORMATION. THE PATIENT WAS TREATED AFTER THE INITIAL RUN WITH LACTATED RINGER¿S, ORAL CALCIUM CARBONATE, AND IV CALCIUM CHLORIDE. AT THE MEDICAL PROVIDER¿S REQUEST, A SAMPLE FROM THE SAME BLOOD DRAW WAS RETESTED ON THE SAME PICCOLO ANALYZER. BASED ON THE RERUN RESULT, TREATMENT THAT BEGAN AT 13:05 WAS DISCONTINUED AT 13:49 PER THE PROVIDER¿S DIRECTION. NO ADVERSE EFFECTS WERE NOTED FROM THE TREATMENT. THE CLINIC REPORTED THAT THE MOST RECENT QC CHECK WAS PERFORMED, AND THE RESULTS WERE WITHIN ACCEPTABLE LIMITS. DURING FOLLOW-UP, THE CUSTOMER INDICATED THEY BELIEVED THE ISSUE WAS ISOLATED AND THAT NO FURTHER ISSUES OCCURRED. THE END USER REPORTED THAT THEY ARE SATISFIED WITH THEIR PICCOLO, HAVE NO ADDITIONAL CONCERNS, AND DECLINED TO RETURN THE ANALYZER FOR FURTHER INVESTIGATION. THE END USER DID NOT DISCLOSE WHETHER A ROOT CAUSE WAS IDENTIFIED. THE BATCH RECORD FOR CMP LOT #6023AC1 REVIEW SHOWED NO UNACCEPTABLE POTASSIUM OR CHLORIDE READINGS DURING MANUFACTURING. THE LOT MET ALL RELEASE CRITERIA WITH NO DEVIATIONS. A COMPLAINT REVIEW IDENTIFIED ONE (1) COMPLAINT (FROM THIS CLINIC) INVOLVING ONE (1) ROTOR LOT REPORTED FOR HIGH POTASSIUM AND CHLORIDE OUT OF 18,020 ROTORS SHIPPED, FOR A COMPLAINT RATE OF 0.005%. THERE HAS BEEN NO OBSERVED TREND IN HIGH POTASSIUM OR CHLORIDE OVER THE LAST 12 MONTHS ENDING IN (B)(6) 2026, WITH NO REPORTED PATIENT IMPACT RESULTING IN INJURY OR HOSPITALIZATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH POTASSIUM (K+) AND CHLORIDE (CL-) RESULT WHEN USING THE PICCOLO XPRESS ANALYZER WITH THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP), LOT #6023AC1. ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179412 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO XPRESS CHEMISTRY ANALYZER JJG ABAXIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown