PICCOLO XPRESS CHEMISTRY ANALYZER
Received May 22, 2026 · Event occurred Apr 23, 2026
Report 2939693-2026-00013 · MDR key 25256232
Device
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH POTASSIUM (K+) RESULT FROM THE PICCOLO XPRESS ANALYZER AND THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP), LOT #5372AA1. ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION.
Additional Manufacturer Narrative
THE END USER EXPECTED THE PICCOLO CMP RESULTS TO MATCH THOSE OF THE EXTERNAL LABORATORY. THE END USER USES AN INTERNALLY ESTABLISHED REFERENCE RANGE (2.5¿5.7 MMOL/L), WHICH DIFFERS FROM THE REFERENCE RANGE STATED IN THE PICCOLO CMP INSTRUCTIONS FOR USE (IFU) (3.6¿5.1 MMOL/L). THE PATIENT WAS NOT TREATED BASED ON THE PICCOLO ANALYZER RESULTS. THE END USER PREFERRED NOT TO DISCLOSE PATIENT HISTORY, DECLINED TROUBLESHOOTING, AND ELECTED TO SEND THE INSTRUMENT IN FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE ISSUED UPON COMPLETION OF THE INVESTIGATION.