MalfunctionCDD
ELECSYS VITAMIN B12 II
Received Jun 4, 2026 · Event occurred May 14, 2026
Report 1823260-2026-02206 · MDR key 25394658
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07028121190
Lot number
938078
Product problems
- High Test Results
Patient
52 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED A HIGH RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS VITAMIN B12 II (VITAMIN B12 II) ON A COBAS E 801 ANALYTICAL UNIT. THE RESULT WAS 1290 PG/ML. THE PHYSICIAN EXPECTED A VERY LOW RESULT AND QUESTIONED THIS RESULT AS IT WAS INCONSISTENT WITH OTHER CLINICAL EVIDENCE.
Additional Manufacturer Narrative
THE E801 ANALYZER SERIAL NUMBER WAS (B)(6).