ELECSYS VITAMIN B12 II
Received Aug 3, 2023 · Event occurred Jul 10, 2023
Report 1823260-2023-02511 · MDR key 17454920
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
707331
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (VITAMIN B12 II) ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL RESULT WAS 112.1 PG/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 147.0 PG/ML AND 247 PG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE E411 ANALYZER SERIAL NUMBER WAS (B)(6). THE CALIBRATION AND QC DATA DO NOT SUGGEST A GENERAL REAGENT ISSUE. SEVERAL SAMPLE PIPETTING ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. REAGENT PIPETTING ALARMS WERE ALSO NOTED. LIQUID FLOW CLEANING WAS LAST PERFORMED ON (B)(6) 2023. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE IS NOT SUSPECTED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.