ELECSYS VITAMIN B12 II
Received Feb 9, 2024 · Event occurred Jan 26, 2024
Report 1823260-2024-00389 · MDR key 18677718
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
ASKU
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED QC WAS ACCEPTABLE. THE CUSTOMER HAS HAD NO FURTHER ISSUES. BASED ON THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS VITAMIN B12 II (VITAMIN B12 II) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT FOR THE 3 PATIENT SAMPLES WAS >2000 PG/ML. THE CUSTOMER PERFORMED A 1:2 DILUTION ON ONE OF THE PATIENT SAMPLES AND THE RESULT WAS APPROXIMATELY 400 PG/ML. DUE TO THE DILUTION RESULT THE CUSTOMER REPEATED THE 3 PATIENT SAMPLES AND THE RESULTS WERE BETWEEN 300 ¿ 400 PG/ML.
Additional Manufacturer Narrative
THE E411 ANALYZER SERIAL NUMBER WAS: (B)(6). THE FIELD SERVICE ENGINEER (FSE) CHECKED THE INSTRUMENT AND DID NOT IDENTIFY ANY ISSUES. INSTRUMENT PERFORMANCE TESTING WAS COMPLETED. THE INVESTIGATION IS ONGOING.