PICCOLO XPRESS CHEMISTRY ANALYZER
Received May 19, 2026 · Event occurred Apr 20, 2026
Report 2939693-2026-00012 · MDR key 25224316
Device
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY LOW POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER AND THE PICCOLO ELECTROLYTE PANEL, LOT# 5245BA3. ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION.
Additional Manufacturer Narrative
THE END USER EXPECTED THE ELECTROLYTE PANEL RESULTS TO MATCH THE INITIAL RESULTS OBTAINED AND TO FALL WITHIN THEIR INTERNALLY ESTABLISHED REFERENCE RANGE (3.0-5.1 MMOL/L) THAT DIFFERS FROM THE RANGE STATED IN THE PICCOLO ELECTROLYTE PANEL INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER TO SUPPORT EVALUATION OF THE TESTING WORKFLOW, PROCESS CONTROLS, AND SAMPLE HANDLING/PROCESSING. CLARIFICATION HAS ALSO BEEN REQUESTED REGARDING THE PATIENT¿S CLINICAL STATUS, INCLUDING WHETHER TREATMENT WAS INITIATED AND WHETHER TROUBLESHOOTING ACTIONS WERE PERFORMED AND, IF SO, WHETHER THEY WERE SUCCESSFUL. AT THIS TIME, 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.