PCT BRAHMS (ROCHE) ELECSYS COBAS E100 V2

Additional Manufacturer Narrative

THE CUSTOMER'S CALIBRATION, QC, SYSTEM ALARM TRACE, AND SAMPLE PRE-ANALYTICAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QC RESULTS ON THE INVESTIGATION'S COBAS 6000 E 601 MODULE WERE OK. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. UPDATED MEDWATCH FIELD D4 EXPIRATION DATE.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). UNIQUE DEVICE IDENTIFIER (UDI) (B)(4). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE PROCALCITONIN ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER REPORTED THE PROCALCITONIN RESULT TO A PHYSICIAN WHO ASKED FOR A RE-MEASUREMENT OF THE SAMPLE. THE CUSTOMER PROVIDED THE SAMPLE FOR AN INVESTIGATION AND THE PATIENT'S SAMPLE WAS TESTED ON A COBAS 6000 E 601 MODULE. THE SAMPLE WAS OUTSOURCED AND WAS TESTED ON A LUMIPULSE ANALYZER. ON (B)(6) 2021, THE PATIENT'S PROCALCITONIN RESULT ON THE CUSTOMER'S E 601 MODULE WAS ">100" NG/ML. ON (B)(6) 2021, THE PATIENT'S UNDILUTED PROCALCITONIN RESULT ON THE INVESTIGATION'S E 601 MODULE WAS ">100" NG/ML. THE INVESTIGATION PERFORMED A 1:4 DILUTION WITH THE PATIENT'S SAMPLE AND THE DILUTED PROCALCITONIN RESULT WAS 108.5 NG/ML. ON (B)(6) 2021, THE PATIENT'S PROCALCITONIN RESULT ON THE OUTSOURCED LUMIPULSE ANALYZER WAS 71.4 NG/ML.