ALINITY C CARBON DIOXIDE REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL 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 DEPRESSED ALINITY C CARBON DIOXIDE RESULTS ON MULTIPLE PATIENTS AND MULTIPLE ANALYZERS WHEN PROCESSED ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING EXAMPLES WERE PROVIDED. (CUSTOMER¿S REFERENCE RANGE 22 - 32 MMOL/L): PAT B, INITIAL RESULT = 10 MMOL/L, REPEAT RESULTS = 25 MMOL/L; PAT C, INITIAL RESULT = 11 MMOL/L, REPEAT RESULTS = 26 MMOL/L; PAT D, INITIAL RESULT = 8 MMOL/L, REPEAT RESULTS = 22 MMOL/L; PAT E, INITIAL RESULT = 8 MMOL/L, REPEAT RESULTS = 22 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.