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	Insufficient Information (4580)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested from the customer to support the review of the testing workflow, process controls, and sample handling/processing, as well as to clarify the complaint details and the patient¿s clinical status, including whether treatment was initiated based on the reported results.The technical representative recommended that the end user return the instrument for further evaluation.At this time, it is unknown whether the end user has elected to send the instrument in for investigation.A follow-up report will be issued upon completion of the investigation.
Event or Problem Description
A health care professional reported an unexpectedly high potassium (k+) result using the piccolo xpress analyzer and the piccolo comprehensive metabolic panel error codes: chem k+ | k+ problem or question chem k+ | k+ 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: 25167104
• Report Number: 2939693-2026-00008
• Device Sequence Number: 13307583
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001/16D20230622T
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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
• Report Date (Section B): 05/13/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 36 YR
• Patient Sex: Female