ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR A 38-YEAR-OLD FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (FREE T4 REFERENCE RANGE 9.0-19.1 PMOL/L); SID (B)(6), INITIAL RESULT = 53.39 PMOL/L, SAMPLE RE-CENTRIFUGED AND REPEATED WITH THE RESULTS = 17.38, PMOL/L, 16.54 PMOL/L. ADDITIONAL LAB RESULTS PROVIDED: PT 39.6 [9.7-12.0], INR 3.0 [0.8-1.2], APTT 60 [21-29]. THE PATIENT¿S CLINICAL PRESENTATION IS ACUTE MYOPERICARDITIS, ACUTE CARDIOGENIC SHOCK, ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AND HEPARIN-INDUCED THROMBOCYTOPENIA. CURRENT MEDICATIONS: CICLOSPORIN, AMIODARONE, LIDOCAINE, FUROSEMIDE, GABAPENTIN, OXYCODONE, PARACETAMOL, CASPOFUNGIN, PIPERACILLIN + TAXOBACTAM, ARGATROBAN, HYDRALAZINE, PHOSPHATE ENEMA, CO-TRIMOXAZOLE, VALGANCICLOVIR, MEXILETINE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.