ELECSYS VITAMIN B12 II
Received Apr 15, 2024 · Event occurred Mar 19, 2024
Report 1823260-2024-01144 · MDR key 19104427
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
76500607
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELD D4 EXPIRATION DATE WAS UPDATED. FURTHER INFORMATION REGARDING THE CASE WAS REQUESTED BUT NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULT FROM A PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THE INITIAL RESULT FROM THE ANALYZER WAS 170 PG/ML. THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 250 PG/ML.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE COBAS E411 DISK WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.