PICCOLO XPRESS CHEMISTRY ANALYZER
Received Jun 26, 2026 · Event occurred May 28, 2026
Report 2939693-2026-00016 · MDR key 25636774
Device
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PATIENT WAS NOT TREATED BASED ON THE PICCOLO ANALYZER RESULTS. THE END USER PREFERRED NOT TO DISCLOSE PATIENT HISTORY. ABAXIS TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING WITH THE CUSTOMER. THE CUSTOMER WAS ADVISED TO REPEAT QC; VERIFY REAGENT/STORAGE CONDITIONS AND EXPIRATION DATES; CONFIRM ENVIRONMENTAL CONDITIONS WERE WITHIN SPECIFICATIONS; AND ENSURE PROPER SPECIMEN HANDLING. INFORMATION REGARDING THE PATIENT¿S PRE-EXISTING CONDITIONS AND/OR CURRENT MEDICATIONS IS UNKNOWN. THE CLINIC WAS PROVIDED WITH MATERIALS TO PERFORM A LINEARITY CHECK AND WAS OFFERED THE OPTION TO SEND THE ANALYZER IN FOR SERVICE. 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.
Description of Event or Problem
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH SODIUM (NA+) RESULT WITH THE PICCOLO XPRESS ANALYZER AND THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP), LOT #611AC1. ERROR CODES: CHEM NA+ / NA+ PROBLEM OR QUESTION.