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	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a discrepancy between the initial and repeat piccolo results and the results from an external laboratory¿s roche analyzer.The patient was not treated based on the piccolo results.The patient was subsequently confirmed to have arrived with severe muscle damage (rhabdomyolysis).Troubleshooting was performed reviewing process and sample handling.The end user was advised of the piccolo basic metabolic panel instructions for use indicating that the piccolo potassium assay is a coupled pyruvate kinase (pk) / lactate dehydrogenase (ldh) method.In cases of extreme muscle trauma or markedly elevated creatine kinase (ck), this assay may yield falsely elevated potassium (k+) values.Therefore, unexpectedly high potassium results should be confirmed using an alternative methodology.The end user declined to send the instrument for further evaluation.A follow-up was conducted, and the customer reported no additional issues.A follow-up report will be submitted 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 basic metabolic panel.Chem high/low: high.Chem k+ | k+ problem or question.
Additional Manufacturer Narrative
The most likely root cause would be interference due to the patient¿s rhabdomyolysis.The customer confirmed that no further issues have occurred.A review of the batch record for lot 5421ab1 showed three unacceptable potassium readings during manufacturing, corresponding to a failure rate of (b)(4).The lot met all release criteria with no deviations.A review of complaint data identified two rotors from this lot reported for high potassium out of (b)(4) rotors shipped, yielding a complaint rate of (b)(4).No trend of high potassium was observed over the last 12 months ending in march 2026.No further actions are required at this time.

• 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: 24985901
• Report Number: 2939693-2026-00005
• Device Sequence Number: 9642492
• Product Code: JJG
• UDI-Device Identifier: EABA110000001
• UDI-Public: +EABA110000001/16D20251218
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 03/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2024
• 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: 20 YR
• Patient Sex: Male