ELECSYS VITAMIN B12 II
Received Jul 17, 2024 · Event occurred Jun 22, 2024
Report 1823260-2024-02058 · MDR key 19763443
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
728618
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
58 YR · Female
- 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 SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE COBAS E411 DISK SERIAL NUMBER WAS (B)(6). THE COBAS E801 SERIAL NUMBER WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 II RESULTS NOT MATCHING BETWEEN A COBAS E411 ANALYZER AND A COBAS E801 ANALYZER. SAMPLE 1 HAD A RESULT FROM THE E411 OF 218.8 PG/ML. THE REPEAT RESULT ON (B)(6) 2024 WAS 257.5 PG/ML. ON (B)(6) 2024, THE RESULT FROM THE COBAS E801 IN ANOTHER LABORATORY WAS 191 PG/ML. THE SAME SAMPLE WAS TESTED ON ANOTHER PLATFORM, "AUTOBIO AUTOLUMO A2000PLUS"; THE RESULT WAS 161.433 PG/ML. ADDITIONAL COMPARISONS: SAMPLE 2 RESULT FROM THE E411 WAS 395.4 PG/ML AND THE RESULT FROM THE E801 WAS 293.0 PG/ML. SAMPLE 3 RESULT FROM THE E411 WAS 254.2 PG/ML AND THE RESULT FROM THE E801 WAS 159.0 PG/ML. SAMPLE 4 RESULT FROM THE E411 WAS 250.4 PG/ML AND THE RESULT FROM THE E801 WAS 106.0 PG/ML.