ELECSYS VITAMIN B12 II
Received Oct 28, 2025 · Event occurred Sep 30, 2025
Report 1823260-2025-04385 · MDR key 23406385
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
839242
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 II RESULTS FROM THE COBAS 6000 E601 MODULE AND COBAS E 411 ANALYZER FOR ONE PATIENT. THE INITIAL RESULT FROM THE MODULE OF THE INITIAL PATIENT SAMPLE WAS 979.9 PG/ML. THE PATIENT WENT TO TWO OTHER LABORATORIES AND OBTAINED THE FOLLOWING RESULTS: THE RESULT FROM THE FIRST LABORATORY THAT USED A MINDRAY ANALYZER WAS 447 PG/ML. THE RESULT FROM THE SECOND LABORATORY USING AN UNKNOWN ANALYZER WAS 499 PMOL/L OR ~678 PG/ML. THE PATIENT QUESTIONED THE INITIAL RESULT. ON (B)(6) 2025, THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE FROM THE COBAS E411 WAS 872.4 PG/ML.
Additional Manufacturer Narrative
THE COBAS 6000 E601 MODULE SERIAL NUMBER IS (B)(6). THE COBAS E 411 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE QC RESULTS PROVIDED WERE WITHIN RANGE. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE QC WAS PASSING PRIOR TO THE EVENT, INDICATING THAT THERE IS NOT A GENERAL OR LOCAL REAGENT ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE, AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION.