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	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The end user expected the initial potassium results to be equivalent to those from the external laboratory.Troubleshooting was declined.The patient was not treated based on the piccolo analyzer results.During follow-up, the customer indicated they believed the issue was isolated and that no further issues occurred.The end user reported that the piccolo is functioning as intended with no additional concerns and declined to return the analyzer for further investigation.The end user did not disclose whether a root cause was identified.Review of the batch record for lot 6022ac3 identified one (1) unacceptable potassium reading during manufacturing, representing a (b)(4) failure rate with a 3% limit.The lot met all release criteria and had no deviations.A review of complaint data showed that one (1) rotor from this lot was reported (from this clinic) for low potassium, out of (b)(4) rotors shipped, for a complaint rate of (b)(4).No trend of low potassium results has been observed over the 12 months ending may 27, 2026, and there has been no reported patient impact contributing to injury or hospitalization.No further action is required at this time.
Event or Problem Description
Error codes: chem k+ | k+ problem or question.A health care professional reported an unexpectedly low potassium (k+) result using the piccolo xpress analyzer and piccolo xpress analyzer and comprehensive metabolic panel (cmp) lot# 6022ac3.

• 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: 25332302
• Report Number: 2939693-2026-00015
• Device Sequence Number: 9861374
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001/16D20231020X
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 05/29/2026

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: 05/14/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• 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 Sex: Unknown