ELECSYS VITAMIN B12 II
Received Sep 5, 2024 · Event occurred Aug 14, 2024
Report 1823260-2024-02569 · MDR key 20148758
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07028121190
Lot number
769866
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Readings
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Readings
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELD D4 EXPIRATION DATE WAS UPDATED. THE CUSTOMER WAS NOT PERFORMING QC FOR THE VARIOUS CONCENTRATION RANGES INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS AS STATED PER PRODUCT LABELING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE COBAS PURE E 402 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 II RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 146 PMOL/L. ON (B)(6) 2024, THE SAME SAMPLE WAS TESTED WITH A NEW REAGENT CASSETTE AND A NEW CALIBRATION WITH A RESULT OF 255 PMOL/L