ELECSYS VITAMIN B12 II
Received Jul 10, 2025 · Event occurred Jun 18, 2025
Report 1823260-2025-02099 · MDR key 22467549
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
E801Catalog number
07028121190
Lot number
832087
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
58 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS VITAMIN B12 ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A VITAMIN B12 VALUE OF < 150 PG/ML. THE VALUE WAS QUESTIONED BY THE DOCTOR SINCE IT DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER, RESULTING IN A VITAMIN B12 VALUE OF 427 PG/ML. THE REPEAT VALUE WAS DEEMED CORRECT. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A VITAMIN B12 VALUE OF 293 PG/ML.
Additional Manufacturer Narrative
THE VITAMIN B12 REAGENT LOT NUMBER WAS 832087. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
CALIBRATION AND CONTROLS WERE ACCEPTABLE. A GENERAL REAGENT ISSUE CAN BE RULED OUT. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY A REVIEW OF ALARM TRACE DATA SHOWED 12 SAMPLE FOAM DETECTION AND SAMPLE SHORT ALARMS. THESE ALARMS INDICATE ISSUES WITH SAMPLE QUALITY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.