PICCOLO XPRESS CHEMISTRY ANALYZER
Received Jul 17, 2026 · Event occurred Jun 24, 2026
Report 2939693-2026-00017 · MDR key 25857143
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. A SAMPLE WAS SENT TO A THIRD-PARTY LABORATORY FOR CONFIRMATION. 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. H3 OTHER TEXT : AWAITING CUSTOMERS DECISION TO RETURN
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 (CMP), LOT#6042FC1 ERROR CODES: CHEM K+ / K+ PROBLEM OR QUESTION.