ACCESS VITAMIN B12 REAGENT
Received Feb 12, 2019 · Event occurred Jan 21, 2019
Report 2122870-2019-01046 · MDR key 8331842
Device
Generic name
Radioassay, B12
Manufacturer
Beckman CoulterModel number
33000Catalog number
33000
Lot number
831320
Product problems
- High Test Results
- High Test Results
Patient
39 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. THE ACCESS B12 REAGENT WAS NOT RETURNED FOR EVALUATION. ALL ASSAY AND SYSTEM VERIFICATIONS MET SPECIFICATIONS AT THE TIME OF THIS INCIDENT. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.
Description of Event or Problem
ON (B)(6) 2019 THE CUSTOMER REPORTED THAT NON-REPRODUCIBLE ELEVATED VITAMIN B12 (ACCESS VITAMIN B12) RESULTS HAD BEEN GENERATED ON THE CUSTOMER'S UNICEL DXI800 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE INITIAL ELEVATED VITAMIN B12 RESULT WAS 219.23 PMOL/L WAS RELEASED FROM THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND REPEATED WITH AN ALTERNATE METHOD (NOT PROVIDED); RESULT PROVIDED WAS <111 PMOL/L. THERE WAS NO REPORT OF CHANGE TO PATIENT CARE OR TREATMENT. CALIBRATION, QUALITY CONTROL AND SYSTEM CHECK WERE ALL PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE INCIDENT. INFORMATION REGARDING PATIENT SAMPLE COLLECTION AND PROCESSING WAS NOT PROVIDED.