PICCOLO XPRESS CHEMISTRY ANALYZER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER TO SUPPORT THE REVIEW OF THE TESTING WORKFLOW, PROCESS CONTROLS, AND SAMPLE HANDLING/PROCESSING, AS WELL AS TO CLARIFY THE COMPLAINT DETAILS AND THE PATIENT¿S CLINICAL STATUS, INCLUDING WHETHER TREATMENT WAS INITIATED BASED ON THE REPORTED RESULTS. THE TECHNICAL REPRESENTATIVE RECOMMENDED THAT THE END USER RETURN THE INSTRUMENT FOR FURTHER EVALUATION. 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.

Description of Event or Problem

A HEALTH CARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH POTASSIUM (K+) RESULT USING THE PICCOLO XPRESS ANALYZER AND THE PICCOLO COMPREHENSIVE METABOLIC PANEL ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION CHEM K+ / K+ PROBLEM OR QUESTION.