ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE VITAMIN B12 II REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS PURE SAMPLE SUPPLY UNIT SERIAL NUMBER WAS (B)(4). QC WAS WITHIN THE RANGES. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM/PLASMA SAMPLE TESTED WITH ELECSYS VITAMIN B12 G2 (VITAMIN B12 II) ASSAY ON A COBAS PURE SAMPLE SUPPLY UNIT. INITIAL RESULT: 107 PG/ML. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AS THE CUSTOMER NOTICED THAT THE RESULT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 318 PG/ML.

Additional Manufacturer Narrative

SECTION D4 WAS UPDATED. CORRECTION: FROM COBAS PURE SAMPLE SUPPLY UNIT TO COBAS E402 IMMUNOASSAY ANALYZER. THE SAMPLE WAS TESTED ON A COBAS E402 SERIAL NUMBER (B)(6). THE CALIBRATION WAS LAST PERFORMED 11 WEEKS BEFORE THE DAY OF THE EVENT AND IT WAS ACCEPTABLE. THE ALARM TRACE AND THE PRE-ANALYTICAL DATA DID NOT SHOW ANY ABNORMALITY. A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.