ELECSYS VITAMIN B12 II
Received Nov 3, 2023 · Event occurred Oct 18, 2023
Report 1823260-2023-03516 · MDR key 18067340
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
07028121190Catalog number
07028121190
Lot number
665073
Product problems
- High Test Results
- High Test Results
Patient
11 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COMPETITOR METHOD WAS THE LK3000V SERIES INSTRUMENT. THE RESULT FROM THE COMPETITOR METHOD WAS BELIEVED TO BE CORRECT. THE PATIENT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. ASSAYS FROM DIFFERENT MANUFACTURERS CAN GENERATE DIFFERENT RESULTS. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE STANDARDIZATION METHODOLOGY USED. BASED ON A REVIEW OF WORLDWIDE DATA OF QC RECOVERY FOR THE REAGENT LOT USED BY THE CUSTOMER, NO REAGENT ISSUE WAS FOUND. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE COMPETITOR METHOD WAS NOT PROVIDED.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (VITAMIN B12 II) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE RESULT FROM THE E801 ANALYZER WAS 983 PMOL/L. THE SAMPLE WAS TESTED BY A COMPETITOR METHOD AND THE RESULT WAS 366 PG/ML (270.12 PMOL/L).
Additional Manufacturer Narrative
**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.