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 IMPRECISE ALINITY CALCIUM2 RESULTS FOR ONE 68-YEAR-OLD MALE PATIENT. PRESENTATION: ITU POST VASCULAR PROCEDURE FOR PERIPHERAL VASCULAR DISEASE AND DIABETIC FOOT INFECTION, T2DM, HAEMORRHAGE, ACUTE HYPERCAPNIC RESPIRATORY FAILURE, AKI, ALCOHOLIC CIRRHOSIS AND PORTAL HYPERTENSTION, ESSENTIAL HYPERTENSION, IRON DEFICIENCY ANAEMIA. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 3.05 REPEATS 3.67, 2.65, 2.37, 2.77, 2.29, 3.38, 2.62, 2.48, 2.31, 2.43, 3.02, 3.33, AND 3.25 MMOL/L. MEDICATIONS: HUMULIN I, NOVORAPID INJECTION, GLYCEROL, FUROSEMIDE, LACTULOSE, MACROGOL, MIRCERA INJECTION, CARVEDILOL, PREDNISOLONE, BUPRENORPHINE PATCH, OCTENIDINE, SENNOSIDES, ANUSOL HC OINTMENT, CETIRIZINE, CHOLECALCIFEROL [SIC], LANSOPRAZOLE, PHOSPHATE ENEMA, CHLORPHENAMINE INJECTION, OXYCODONE ORAL, ENOXAPARIN EVERY EVENING SC, PARACETAMOL, LINAGLIPTIN, NALOXONE, ONDANSETRON, CYCLIZINE, RIFAXIMIN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.