COBAS® BKV (192)

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING,

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE EBV RESULTS FOR ONE PATIENT SAMPLE USING THE COBAS® BKV ASSAY FOR USE ON THE COBAS 58/68/8800 SYSTEMS. ON (B)(6) 2024, THE ALLEGED SAMPLE HAD A RESULT OF 16,982 IU/ML. ON (B)(6) 2024, A NEW SAMPLE INITIALLY GENERATED A RESULT OF 224 IU/ML WHICH WAS QUESTIONED BY THE DOCTOR AND PROMPTED THE REPEAT. ON (B)(6) 2024, THE SAME SAMPLE WAS REPEATED AND A RESULT OF 79,600 IU/ML WAS GENERATED. THE DOCTOR INDICATED THIS ALIGNED CLOSER TO THE CLINICAL PICTURE. A NEW SAMPLE WAS OBTAINED FROM THE SAME PATIENT ON (B)(6) 2024 AND THE SAMPLE GENERATED A RESULT OF 16,218 IU/ML ON (B)(6) 2024.

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE WAS FOUND TO BE CUSTOMER HANDLING/WORKFLOW-RELATED ISSUES INCLUDING BUT NOT LIMITED TO THE FOLLOWING: SAMPLE STORAGE, SAMPLE PREP INCLUDING CENTRIFUGATION/VORTEXING, AND ALIQUOTING OF THE SAMPLE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY.