ELECSYS VITAMIN B12 II
Received Feb 21, 2025 · Event occurred Jan 31, 2025
Report 1823260-2025-00514 · MDR key 21432843
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
792322
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible 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 A QUESTIONABLE ELECSYS VITAMIN B12 II RESULT FROM THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 90 PG/ML, AND THE REPEAT RESULT WAS 223 PG/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.
Additional Manufacturer Narrative
THE COBAS E 411 ANALYZER (RACK SYSTEM) SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
MEDWATCH FIELD D4 LOT NO WAS UPDATED. A FIELD SERVICE ENGINEER (FSE) PERFORMED A SIPPER PIPETTE PRIME AND OBSERVED THAT THE WATER DID NOT FLOW AS EXPECTED. THE SIPPER LINE, SOLENOID VALVES, AND THE PINCH VALVE TUBING WERE CHECKED, WHICH RESOLVED THE ISSUE. THE DEVICE WAS TURNED OVER TO THE CUSTOMER IN GOOD CONDITION. THE PROVIDED CALIBRATION DATA ON 17-JAN-2025 AND QC DATA ON 10-JAN-2025 WERE ACCEPTABLE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.