BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 23499106 · Received November 7, 2025

    Report

    Report Number
    2939693-2025-00003
    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
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT NO.1 FEMALE 32 YEARS OLD (B)(6) 2025 22:47: A WHOLE BLOOD (WB) SAMPLE WAS COLLECTED AND ANALYZED USING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(6) AMLYTE 13 PANEL LOT 5265AB3 RESULTS: (CRE)= 4.3 MG/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 XPRESS ANALYZER RESULTS: SALINE SOLUTION, AMLODIPINE, AND PARACETAMOL. RERUN: (B)(6) 2025 08:57: A NEW WB SAMPLE WAS COLLECTED AND ANALYZED USING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(6) AMLYTE 13 PANEL LOT 5242AA5 RESULTS: (CRE)= 1.3 MG/DL (REFERENCE RANGE: 0.2-20 MG/DL) THE FOLLOWING TREATMENT WAS ADMINISTERED: ANTIHYPERTENSIVE THERAPY WITH AMLODIPINE WAS PRESCRIBED DUE TO RENAL INSUFFICIENCY (ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS OR ANGIOTENSIN RECEPTOR BLOCKERS (ARBS) ¿SARTANS¿ WERE EXCLUDED AS FIRST-LINE OPTIONS DUE TO THE PATIENT'S AGE). IT IS UNKNOWN WHETHER THESE TREATMENTS WERE BASED ON THE PICCOLO XPRESS ANALYZER RESULTS ALONE. PATIENT NO.2 MALE, 66 YEARS OLD. (B)(6) 2025 23:08: A WB SAMPLE WAS DRAWN FROM THE PATIENT AND ANALYZED USING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(6), AND THE PICCOLO AMLYTE 13 PANEL LOT 5265AB3. 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 XPRESS ANALYZER RESULTS: A SALINE SOLUTION, ARTOSILENE 1-VIAL (160 MG), HACION 125 MG, CALCIPARINA 12,500 IU-1 VIAL, ADMINISTERED SUBCUTANEOUSLY. PICCOLO XPRESS ANALYZER P23064 HAS BEEN REPORTED IN A SEPARATE MIR UNDER THE MANUFACTURER'S REFERENCE NUMBER: (B)(4) AND MDR 2939693-2025-00004. RERUN: (B)(6) 2025 06:39: A WB SAMPLE WAS COLLECTED AND ANALYZED USING THE PICCOLO XPRESS 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: CALCIPARINA 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 XPRESS ANALYZER RESULTS ALONE. PATIENT NO.3 FEMALE 35 YRS. (B)(6) 2025 23:38: A WB SAMPLE WAS COLLECTED AND ANALYZED USING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(6) AMLYTE 13 PANEL LOT 5184AA3 RESULTS: (CRE)= 4.6 MG/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 XPRESS ANALYZER RESULTS: SALINE SOLUTION, INTRAVENOUS PARACETAMOL, PLASIL, AMLODIPINE RERUN: (B)(6) 2025 01:39: A NEW WB SAMPLE WAS COLLECTED AND ANALYZED USING AN UNKNOWN EXTERNAL ANALYZER. RESULTS: (CRE)= 0.83 MG/DL (UNKNOWN REFERENCE RANGE). REQUESTING FURTHER CLARIFICATION OF COMPLAINT DETAILS. A 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 IDENTIFY PRE-ANALYTICAL ISSUES AND SAMPLE-HANDLING ISSUES. DESPITE MULTIPLE REQUESTS, THE CUSTOMER DID NOT PROVIDE CLARIFICATION ON THE COMPLAINT DETAILS, LEAVING IT UNCLEAR WHETHER THE TREATMENTS WERE BASED SOLELY ON PICCOLO XPRESS ANALYZER RESULTS. REPEAT TESTING PERFORMED ON TWO PICCOLO ANALYZERS AND AN UNKNOWN EXTERNAL INSTRUMENT CONSISTENTLY PRODUCED VALUES WITHIN THE NORMAL RANGE, SUPPORTING THE ACCURACY OF THE RESULTS. ALTHOUGH A RETURN MERCHANDISE AUTHORIZATION (RMA) WAS INITIATED FOR FURTHER INVESTIGATION, THE CUSTOMER INDICATED THEY WERE NO LONGER CONCERNED AND DECLINED TO RETURN THE DEVICE. BATCH RECORD REVIEWS FOR LOTS 5184AA3, 5265AB3, AND 524AA5 CONFIRMED THAT ALL MET RELEASE CRITERIA WITH NO DEVIATIONS. ANALYSIS OF COMPLAINT DATA REVEALED NO COMPLAINTS OTHER THAN THE CURRENT CASE AND ONE ADDITIONAL LOW CREATININE REPORT¿BOTH SUBMITTED BY THE SAME CUSTOMER¿WITH NO OBSERVED TRENDS OR INCREASES IN COMPLAINT RATES FOR THESE LOTS. AS THE COMPLAINT OF LOW CREATININE COULD NOT BE CONFIRMED, NO FURTHER ACTION IS REQUIRED AT THIS TIME; ZOETIS WILL CONTINUE ONGOING VIGILANCE AND POST-MARKET SURVEILLANCE TO MONITOR PRODUCT PERFORMANCE AND SAFETY. H3 OTHER TEXT: CUSTOMER DECLINED RMA.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED AN UNEXPECTED LOW CREATININE (CRE) RESULT USING THE PICCOLO XPRESS ANALYZER, SERIAL NUMBER (B)(6), AND THE PICCOLO AMLYTE 13 PANEL, LOTS 5184AA3, 5265AB3, 5242AA5, INVOLVING THREE PATIENTS. CHEM HIGH/LOW: LOW ERROR CODES: CHEM CRE / CREAT PROBLEM OR QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861962 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO XPRESS CHEMISTRY ANALYZER JJG ABAXIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown