BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 23662588 · Received November 26, 2025

    Report

    Report Number
    2939693-2025-00005
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 2, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    UDI-DI
    EABA110000001
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    02OCT2025/ UNKNOWN TIME: A WHOLE BLOOD (WB) SAMPLE WAS ANALYZED USING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER: (B)(6), AND THE PICCOLO CMP PANEL, LOT: 5222BC1. RESULTS: CREATININE (CRE)= 4.3* MG/DL (REFERENCE RANGE: 0.6-1.2 MG/DL). RERUN: 02OCT2025/UNKNOWN TIME: THE SAME SAMPLE FROM THE PREVIOUS RUN WAS SENT TO AN EXTERNAL LABORATORY, AND PLASMA WAS ANALYZED USING AN ABBOTT ALINITY. RESULTS: CREATININE (CRE)= 0.73 MG/DL (REFERENCE RANGE: 0.7-1.5MG/DL). REPEAT: 02OCT2025/ UNKNOWN TIME: A WHOLE BLOOD (WB) SAMPLE WAS ANALYZED USING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER: (B)(6) PICCOLO CMP PANEL, LOT: 5222BC1. RESULTS: CREATININE (CRE)=0.9 MG/DL (REFERENCE RANGE: 0.6-1.2 MG/DL). ZOETIS REQUESTED FURTHER CLARIFICATION OF THE COMPLAINT DETAILS. THE PATIENT RECEIVED TREATMENT; HOWEVER, THE SPECIFIC TREATMENT ADMINISTERED, AND THE TIME OF ADMINISTRATION ARE UNKNOWN. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN RECOMMENDED FOR FURTHER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    29OCT2025: ZOETIS UNION CITY TECHNICAL SUPPORT RECEIVED A CALL FROM A HEALTHCARE PROFESSIONAL REPORTING AN UNEXPECTED HIGH CREATININE (CRE) RESULT USING THE PICCOLO XPRESS ANALYZER, SERIAL NUMBER: (B)(6), AND THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP) LOT: 5222BC1. THE PATIENT WAS TREATED. CHEM HIGH/LOW: HIGH, ERROR CODES: CHEM CRE / CREAT PROBLEM OR QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912907 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO XPRESS CHEMISTRY ANALYZER JJG ABAXIS, INC. EABA110000001

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female