MAUDE Adverse Event Report: ABAXIS, INC. PICCOLO XPRESS CHEMISTRY ANALYZER

Catalog Number	1100-0000
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Abaxis technical information troubleshooting was offered; however, the end user declined troubleshooting and elected not to return the instrument for further evaluation.Although the customer initially reported the issue for abaxis awareness, they subsequently confirmed the instrument was functioning satisfactorily.Information regarding the patient¿s pre-existing conditions and/or current medications is unknown.The root cause was not established.There was no patient impact, and the event did not contribute to patient injury or hospitalization.The customer also confirmed that no further issues have occurred.A review of the batch record for cmp lot 5493ac6 showed there was one (1) unacceptable reading for sodium in manufacturing, for a failure rate of 0.2 % with a limit of 3 %.No unacceptable chloride results were observed during manufacturing.The lot met all release criteria with no deviations.Complaint data showed that only one (1) rotor from this lot, reported by the same customer clinic, was associated with high sodium and chloride results out of 22,270 rotors shipped, corresponding to a complaint rate of (b)(4).No trend of high sodium or chloride was observed over the 12-month period ending in april.No further actions are required at this time.
Event or Problem Description
Chem high/low: high error codes: chem na+ | na+ problem or question.
Additional Manufacturer Narrative
Corrected event description.
Event or Problem Description
A health care professional reported an unexpected high-test result on sodium (na+) and chloride (cl) using the piccolo xpress analyzer, serial number (b)(6) and the comprehensive metabolic panel (cmp) lot 5493ac6.The patient was not treated error codes: chem na+ | na+ problem or question.Chem cl| cl problem or question.

• Brand Name: PICCOLO XPRESS CHEMISTRY ANALYZER
• Common Device Name: PICCOLO XPRESS CHEMISTRY ANALYZER
• Manufacturer (Section D): ABAXIS, INC.; 3240 whipple road; union city CA 94587
• Manufacturer (Section G): ABAXIS, INC.; 3240 whipple road; union city CA 94587 1217
• Manufacturer Contact: david longwell ; 3240 whipple road; union city, CA 94587-1217
• MDR Report Key: 25062166
• Report Number: 2939693-2026-00007
• Device Sequence Number: 15802623
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001/16D20230208W
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K934592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1100-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female