T2CANDIDA 1.1 PANEL

Additional Manufacturer Narrative

THE T2CANDIDA 1.1 PANEL RESULTED IN A POSITIVE CANDIDA PARAPSILOSIS RESULT ON A NEGATIVE CLINICAL SAMPLE USING T2DX INSTRUMENT I(B)(4). THE CUSTOMER REPORTED THE FALSE POSITIVE RESULT AS COMPARED TO NEGATIVE BLOOD CULTURE OF THE SAME VENOUS COLLECTION. PATIENT DETAILS WERE NOT PROVIDED. BASED ON THE INFORMATION PROVIDED BY THE DISTRIBUTOR, THERE WAS NO ALLEGATION FROM THE INSTITUTION THAT THE ALLEGED FALSE POSITIVE LED TO AN ADVERSE EVENT OR PATIENT HARM. SPECIFIC RUN DATA WAS TRANSFERRED TO T2 BIOSYSTEMS FOR REVIEW/EVALUATION AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CLINIC ON 13SEP2022; THE T2CANDIDA 1.1 PANEL AND ASSOCIATED BLOOD SAMPLES WERE DISCARDED AFTER USE. REVIEW OF THE DESIGN HISTORY RECORDS OF THE ASSOCIATED T2CANDIDA 1.1 LOT (WO-20913) RESULTED IN NO FINDINGS RELATED TO PRODUCT QUALITY. FSE OBSERVATION OF THE CUSTOMER'S SAMPLE PREPARATION METHODS SUGGESTED PROCEDURES THAT DEVIATED FROM THE IFU. T2 BIOSYSTEMS SERVICE ADVISED ON BEST PRACTICES FOR SAMPLE HANDLING AND INSTRUMENT MAINTENANCE ACCORDING TO THE IFU AND OPERATOR MANUAL.

Description of Event or Problem

ON 30 AUGUST 2022, A T2 DISTRIBUTOR RELAYED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE RESULT USING THE T2CANDIDA 1.1 PANEL.