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

Catalog Number	1100-0000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a discrepancy between the initial and external laboratory results.Troubleshooting was performed by reviewing the process; however, the end user was not comfortable sharing their sample-handling process.The end user declined to send the instrument for further evaluation and requested a loaner unit for side-by-side testing.A follow-up was conducted, and the customer reported that after side-by-side testing, they are satisfied with their piccolo and have no additional concerns.The end user did not disclose whether they found the root cause.A review of the batch record for 5401da1 showed that there were no unacceptable readings for potassium during manufacturing and the lot met all release criteria with no deviations.A review of the complaint data identified that there was only one rotor from this lot, reported only from this clinic, for low potassium out of (b)(4) rotors shipped for a complaint rate of (b)(4).There has been no reported patient impact contributing to patient injury or hospitalization.No further action is required at this time.
Event or Problem Description
A health care professional reported an unexpectedly low potassium (k+) result using the piccolo xpress analyzer and the piccolo renal panel, lot#5401da1.The patient was not treated error codes: 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: 25129199
• Report Number: 2939693-2026-00010
• Device Sequence Number: 15783373
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001/16D20251205Y
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K934592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: 04/08/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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 Sex: Unknown