ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E411 DISK IS (B)(6) . THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FERRITIN (FERRITIN), ELECSYS VITAMIN D TOTAL III, AND ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THIS MEDWATCH IS FOR THE ELECSYS VITAMIN B12 IMMUNOASSAY. PLEASE REFER TO THE MEDWATCH WITH: A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS VITAMIN D TOTAL III ASSAY. A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS FERRITIN (FERRITIN) ASSAY. THE INITIAL VITAMIN B12 II RESULT WAS <50.00 PG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 630.9 PG/ML. THE REPEAT RESULT WAS DEEMED CORRECT BASED ON THE PATIENT'S PREVIOUS RESULTS AND CORRELATION WITH THE PATIENT'S COMPLETE BLOOD COUNT (CBC) BY THE LABORATORY DOCTOR.

Additional Manufacturer Narrative

THE INVESTIGATION REVIEWED THE ALARM TRACE; NO ISSUES WERE NOTED. THE INVESTIGATION REVIEWED THE CUSTOMER'S HANDLING OF PATIENT SAMPLES. THE PATIENT SAMPLE'S CLOTTING TIME WAS ONLY 10 MINUTES; MOST SAMPLE TUBE MANUFACTURERS RECOMMEND A CLOTTING TIME OF 30 MINUTES. THE CUSTOMER USES A FIXED CENTRIFUGE WHICH CAN LEAD TO SLANTED SEDIMENTS RESULTING IN POOR SAMPLE QUALITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.