TP2

Additional Manufacturer Narrative

NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE DATA WAS REQUESTED FOR INVESTIGATION BUT IT WAS NOT PROVIDED DESPITE SEVERAL REMINDERS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE COBAS C111 ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH TOTAL PROTEIN 400T (TP2) ASSAY ON A COBAS C111 ANALYZER. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 5.9 MG/DL. REPEAT RESULT: 7.2 MG/DL (TESTED WITH A NEW REAGENT VIAL). THE UNIT OF MEASUREMENT OF MG/DL WAS REQUESTED TO BE VERIFIED BUT A CLARIFICATION WAS NOT RECEIVED YET. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 6.0. REPEAT RESULT: 7.1 (TESTED WITH A NEW REAGENT VIAL). THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND REQUESTED THE SAMPLES TO BE REPEATED.