ELECSYS VITAMIN B12 II
Received Jun 26, 2025 · Event occurred Jun 6, 2025
Report 1823260-2025-01957 · MDR key 22335954
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
806422
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low 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 SERIAL NUMBER OF THE E 411 ANALYZER IS (B)(6). NO CALIBRATION INFLUENCE WAS OBSERVED. QUALITY CONTROLS WERE WITHIN RANGE PRIOR TO SAMPLE MEASUREMENT. A GENERAL REAGENT OR ANALYZER ISSUE WAS NOT PRESENT. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS VITAMIN B12 II ON A COBAS E 411 ANALYZER. THE SAMPLE INITIALLY RESULTED IN A VITAMIN B12 VALUE OF < 50.00 PG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 513.0 PG/ML.
Additional Manufacturer Narrative
A REVIEW OF ALARM TRACE DATA SHOWED NO RELEVANT ALARMS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.