ELECSYS VITAMIN B12 II
Received Aug 21, 2023 · Event occurred Jul 12, 2023
Report 1823260-2023-02717 · MDR key 17591119
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsCatalog number
07212771190
Lot number
707331
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) PERFORMED ROUTINE MAINTENANCE AND SERVICE. THE FSE NOTED THAT THE LIQUID FLOW CLEANING (LFC) SYSTEM WAS WORKING FINE. HE PERFORMED MECHANICAL AND PRECISION CHECKS WITH SUCCESSFUL RESULTS. THE INVESTIGATION EXCLUDED A GENERAL REAGENT PROBLEM. 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 QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E411 DISK. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF A QUESTIONABLE RESULT. THE INITIAL RESULT WAS GREATER THAN 2000 PG/ML. THE REPEAT RESULT WAS 225.2 PG/ML. THE REPEAT RESULT WAS CROSS-CHECKED ON THE LABORATORY'S OTHER E 411 AND NO SIGNIFICANT VARIATION WAS NOTED.