ARCHITECT C8000 SYSTEM

Description of Event or Problem

THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED A FALSELY ELEVATED POTASSIUM (K+) RESULT ON ONE PATIENT SAMPLE. THE RESULTS PROVIDED WERE: 6.9 / 4.5 (NORMAL RANGE 3.4-4.9). THE CUSTOMER VERIFIED THAT ALL MAINTENANCE IS UP-TO-DATE. ICT MODULE DAYS ON BOARD = 57 WITH A STATUS OF EXCEEDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

Additional Manufacturer Narrative

(B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

EVALUATION INCLUDED A REVIEW OF COMPLAINT TEXT, SERVICE HISTORY, COMPLAINT AND INTERNAL INFORMATION, AND A REVIEW OF LABELING. THE CUSTOMER REPORTED THAT A FALSELY ELEVATED POTASSIUM RESULT WAS GENERATED ON THE ARCHITECTC8000 (SERIAL NUMBER (B)(4)). THE COMPLAINT TEXT INDICATED NO LEAKS WERE OBSERVED FROM THE 1 ML SYRINGES, SAMPLE SYRINGES, OR REAGENT SYRINGES. A STATUS OF 'EXCEEDED' WAS DISPLAYED FOR THE ICT MODULE (SERIAL NUMBER (B)(4)), WHICH HAD BEEN ON-BOARD FOR 57 DAYS. A REVIEW OF LABELING SHOWS PROBABLE CAUSES AND CORRECTIVE ACTIONS RELEVANT TO THE ISSUE OF ERRATIC RESULTS OR POOR PRECISION. A SINGLE DEFINITIVE CAUSE OF THE ISSUE WAS NOT IDENTIFIED; MULTIPLE PARTS WERE REPLACED BY FIELD SERVICE AND THE CUSTOMER REPLACED THE ICT MODULE. BASED ON THE AVAILABLE INFORMATION, POSSIBLE CONTRIBUTING FACTORS FOR THE ELEVATED POTASSIUM RESULTS ARE REAGENT PROBE CARRYOVER OF LACTIC ACID AND/OR SAMPLE INTEGRITY. THE LACTIC ACID R1 REAGENT HAS A HIGH CONCENTRATION OF POTASSIUM WHICH MAY CARRYOVER IF THE R1 PROBE IS WORN, DIRTY, OR DAMAGED. THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A DEVICE MALFUNCTION CAUSED THE RESULT ISSUE. NOR IS THERE AN INDICATION OF A DEFICIENCY OF THE ARCHITECT C8000.