ALINITY C CARBON DIOXIDE REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CARBON DIOXIDE FOR A 46-YEAR-OLD MALE. THE RESULTS WERE HELD BY THE MIDDLEWARE FOR THE ANION GAP GENERATING A RESULT OF <6 MMOL/L AND WHEN THE SAMPLE WAS REPEATED, THE CO2 RESULT WAS LOWER. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6). INITIAL CO2 RESULT= 32 MMOL/L; REPEAT RESULT= 28 MMOL/L (REFERENCE RANGE 22 - 29 MMOL/L). ADDITIONAL RESULTS PROVIDED: INITIAL SODIUM RESULT= 137 MMOL/L; REPEAT RESULT= 140 MMOL/L (REFERENCE RANGE 136 ¿ 145 MMOL/L). INITIAL CHLORIDE RESULT= 104 MMOL/L; REPEAT RESULT= 105 MMOL/L (REFERENCE RANGE 98 ¿ 107 MMOL/L). INITIAL POTASSIUM RESULT= 4.4 MMOL/L; REPEAT RESULT= NOT PROVIDED (REFERENCE RANGE 3.5 ¿ 5.1 MMOL/L). INITIAL ANION GAP RESULT= 1 MMOL/L; REPEAT RESULT= 7 MMOL/L (REFERENCE RANGE 6 ¿ 16 MMOL/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.