ALINITY C CALCIUM2

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 CALCIUM2 ON THE ALINITY C PROCESSING MODULE FOR A 3-YEAR-OLD FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: 8.8 MG/DL TO 10.8 MG/DL): SID: (B)(6), INITIAL CALCIUM RESULT= 13.2 MG/DL (ALINITY (B)(6)); REPEAT RESULTS= 23.7 MG/DL; 9.96 MG/DL ((B)(6)) AND 10.69 MG/DL ((B)(6)). ON (B)(6) 2026, REPLICATES WERE PERFORMED IN THE ALINITY (B)(6) 9.39 MG/DL, 9.29 MG/DL, 9.47 MG/DL AFTER CENTRIFUGATION: 9.43 MG/DL, 9.14 MG/DL, 9.19 MG/DL; REPEAT RESULT= 10 MG/DL ((B)(6)). ADDITIONAL LAB RESULTS PROVIDED: IGM RESULT= 44 MG/DL; IGA RESULT= 139 MG/DL; IGG RESULT= 1039 MG/DL; CREATININE RESULT= 0.4 MG/DL; TOTAL PROTEIN RESULT= 7.85 G/DL; LIPEMIA= 4 INDEX (0); ICTERUS= 0.6 INDEX (0); HEMOLYSIS= 83 INDEX (+1). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.