ELECSYS VITAMIN B12 II
Received May 24, 2024 · Event occurred May 2, 2024
Report 1823260-2024-01563 · MDR key 19394724
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07028121190
Lot number
769866
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (B12 II) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <100 PG/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE CLINICIAN DID NOT AGREE WITH THE RESULT AS IT WAS NOT CONSISTENT WITH THE PATIENT¿S PRIOR RESULT. THE REPEAT RESULT WAS 1388 PG/ML.
Additional Manufacturer Narrative
THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. INSTRUMENT PERFORMANCE TESTING FROM (B)(6) 2024 WAS ACCEPTABLE. REPEATABILITY TESTING WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.