ELECSYS VITAMIN B12 II
Received Mar 16, 2023 · Event occurred Feb 23, 2023
Report 1823260-2023-00840 · MDR key 16555876
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
B12 G2Catalog number
07212771190
Lot number
643757
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELD D4: EXPIRATION DATE WAS UPDATED.
Additional Manufacturer Narrative
THE QUALITY CONTROL RESULTS WERE WITHIN RANGE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE VITAMIN B12 G2 ELECSYS RESULTS FROM COBAS 6000 E601 MODULE SERIAL NUMBER: (B)(4). SAMPLE 1 INITIAL RESULT WAS 75.0 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 179.0 PG/ML. SAMPLE 2 INITIAL RESULT WAS 179.9 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 268 PG/ML. SAMPLE 3 INITIAL RESULT WAS 195.1 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 272 PG/ML. SAMPLE 4 INITIAL RESULT WAS 156.2 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 260 PG/ML. SAMPLE 5 INITIAL RESULT WAS 104.9 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 264 PG/ML. SAMPLE 6 INITIAL RESULT WAS 180.0 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 402 PG/ML. SAMPLE 7 INITIAL RESULT WAS 129.2 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 392 PG/ML. SAMPLE 8 INITIAL RESULT WAS 174.2 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 436 PG/ML. SAMPLE 9 INITIAL RESULT WAS 213 PG/ML. THE RESULT FROM AN ADVIA ANALYZER WAS 740 PG/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.