BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 23501015 · Received November 7, 2025

    Report

    Report Number
    2939693-2025-00004
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 24, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    UDI-DI
    EABA11000000E1
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025 23:08: A WHOLE BLOOD (WB) SAMPLE WAS DRAWN FROM THE PATIENT AND ANALYZED USING THE PICCOLO EXPRESS ANALYZER SERIAL NUMBER (B)(6), AND THE PICCOLO AMLYTE 13 PANEL LOT 5265AB3. PICCOLO EXPRESS ANALYZER SERIAL NUMBER (B)(6) HAS BEEN REPORTED IN A SEPARATE MDR UNDER THE MANUFACTURE REFERENCE NUMBER: (B)(4), MDR 2939693-2025-00003 RESULTS: CREATININE (CRE)= 4.1MG/DL (REFERENCE RANGE: 0.2-20 MG/DL). THE FOLLOWING TREATMENTS WERE ADMINISTERED TO THE PATIENT; HOWEVER, IT IS UNKNOWN WHETHER THESE TREATMENTS WERE BASED ON THE PICCOLO EXPRESS ANALYZER RESULTS: SALINE SOLUTION, ARTOSILENE 1-VIAL(160 MG), HACION 125 MG, CALCIPARIN 12,500 IU-1 VIAL ADMINISTERED SUBCUTANEOUSLY. RERUN: (B)(6) 2025 06:39: A WB SAMPLE WAS COLLECTED AND ANALYZED USING THE PICCOLO EXPRESS ANALYZER SERIAL NUMBER (B)(6) AMLYTE 13 PANEL LOT 51842AA3. RESULTS: (CRE)= 0.6MG/DL (REFERENCE RANGE: 0.2-20 MG/DL). THE FOLLOWING TREATMENT WAS ADMINISTERED: CALCIPARIN THERAPY WAS INITIATED INSTEAD OF LOW MOLECULAR WEIGHT HEPARIN (LMWH) OR DIRECT ORAL ANTICOAGULANTS (DOAC) DUE TO RENAL INSUFFICIENCY. IT IS UNKNOWN WHETHER THESE TREATMENTS WERE BASED ON THE PICCOLO EXPRESS ANALYZER RESULTS ALONE. A REQUEST FOR FURTHER CLARIFICATION OF THE COMPLAINT DETAILS FROM THE END USER AND RETURN MERCHANDISE AUTHORIZATION (RMA) HAS BEEN INITIATED FOR FURTHER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER TO INVESTIGATE POSSIBLE PRE-ANALYTICAL AND SAMPLE-HANDLING ISSUES; HOWEVER, THE CUSTOMER DID NOT PROVIDE CLARIFICATION REGARDING THE COMPLAINT DETAILS, AND IT IS UNKNOWN WHETHER TREATMENTS WERE BASED SOLELY ON PICCOLO XPRESS ANALYZER RESULTS. ALTHOUGH A RETURN MERCHANDISE AUTHORIZATION (RMA) WAS INITIATED FOR FURTHER INVESTIGATION, THE CUSTOMER INDICATED THAT THEY WERE NO LONGER CONCERNED AND CHOSE NOT TO RETURN THE INSTRUMENT. A REVIEW OF BATCH RECORDS FOR LOT 5265AB3 CONFIRMED THAT ALL RELEASE CRITERIA WERE MET, WITH NO DEVIATIONS, AND COMPLAINT DATA SHOWED ONLY ONE OTHER REPORT OF LOW CREATININE, ALSO FROM THE SAME CUSTOMER, WITHOUT ANY OBSERVED TRENDS OR INCREASES IN COMPLAINT RATES FOR THIS LOT. IN SUMMARY, THE COMPLAINT OF LOW CREATININE COULD NOT BE CONFIRMED, AND NO FURTHER ACTION IS REQUIRED AT THIS TIME; ZOETIS WILL CONTINUE TO MONITOR PRODUCT PERFORMANCE AND SAFETY THROUGH ONGOING POST-MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION D1,D2,AND D4.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED AN UNEXPECTED LOW CREATININE (CRE) RESULT USING THE PICCOLO EXPRESS ANALYZER, SERIAL NUMBER (B)(6), AND THE PICCOLO AM LYTE 13 PANEL, LOT 5265AB3. CHEM HIGH/LOW: LOW ERROR CODES: CHEM CRE / CREAT PROBLEM OR QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171404 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO XPRESS CHEMISTRY ANALYZER JJG ABAXIS, INC. EABA11000000E1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male