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

Catalog Number	1100-0000
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient was discharged to follow up with their provider.The end user could not provide details regarding the treatment administered and its timing.They were not directly involved with the patient and do not have access to this information.A follow-up report will be submitted upon completion of the investigation.It is unknown whether the end user will return their instrument for evaluation.
Event or Problem Description
10nov2025: zoetis union city technical support received a call from a healthcare professional reporting an unexpected low potassium (k+) result using the piccolo xpress analyzer, serial number (b)(6), and the piccolo basic metabolic panel (bmp), lots 5235aa3,5182ab1, and piccolo comprehensive metabolic panel (cmp) lot 5301bc0.The patient was treated.The customer expressed concern about the accuracy of the piccolo xpress analyzer sn (b)(6) after comparing potassium (k+) results from the same sample run on their second piccolo xpress analyzer (b)(6) using the piccolo cmp panel, lot 5301bc01.The expectation was that both the bmp panel and the comparison cmp panel would yield similar potassium results.Chem high/low: low error codes: chem k+ | k+ problem or question.
Additional Manufacturer Narrative
During troubleshooting, the technical service representative sent new pipettes to the customer to ensure that calibrated pipettes are being used during sample handling.The analyzer was returned for investigation without the compact flash (cf) card.As a result, instrument details and configuration data were unavailable, and a pre-evaluation chemistry test could not be done due to the absence of baseline results for comparison.A new cf card was installed to verify basic mechanical operation.The optics assembly failed due to crosstalk at the 550 nm filter channel, a condition that can be attributed to inconsistent chemistry results.The main optics assembly was replaced, and the analyzer was cleaned.All required functional testing was performed.The analyzer passed bi-level and verification sample chemistry tests post repairs.The failed optics assembly and contamination (blood spatter in the disc drawer) likely contributed to the inconsistent chemistry.Low potassium results may be due to improper sample handling, a contaminated analyzer, or unknown interferences in the whole blood sample.Additionally, the patient's medical history is unknown.The customer has received the analyzer back with no further concerns.A review of the batch record showed no unacceptable potassium readings during manufacturing, and the piccolo bmp panel 5235aa3 met all release criteria with no deviations.A review of the complaint data showed that 5 rotors from this lot, all from this clinic, were reported for low potassium out of (b)(4) rotors shipped, for a complaint rate of (b)(4).There has been no observed trend in low potassium over the last 12 months ending in nov 2025, and no reported patient impact contributing or resulting in injury or hospitalization.

• 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: tracy morton ; 3240 whipple road; union city, CA 94587-1217
• MDR Report Key: 23746610
• Report Number: 2939693-2025-00007
• Device Sequence Number: 5904417
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001/16D20231101Q
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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: 18 YR
• Patient Sex: Female