ELECSYS VITAMIN B12 II
Received Jul 12, 2023 · Event occurred May 31, 2023
Report 1823260-2023-02224 · MDR key 17308901
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
B12 G2Catalog number
07212771190
Lot number
70733100
Product problems
- Imprecision
- Low Test Results
- Non Reproducible Results
- Imprecision
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS VITAMIN B12 II ON A COBAS E411 DISK. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER LOADED A NEW VITAMIN B12 REAGENT PACK ON THE INSTRUMENT AND PERFORMED A CALIBRATION. THE CONTROL RECOVERED 2 STANDARD DEVIATIONS LOWER THAN THE MEAN. THE PATIENT SAMPLE WAS THEN INITIALLY TESTED AND RESULTED IN A VITAMIN B12 VALUE OF 178.5 PG/ML. THE CUSTOMER THEN RE-CALIBRATED THE VITAMIN B12 REAGENT WITH NEW CALIBRATOR MATERIAL AND THE CONTROL RECOVERED 2 STANDARD DEVIATIONS ABOVE THE MEAN. THE PATIENT SAMPLE WAS THEN REPEATED, RESULTING IN A VITAMIN B12 VALUE OF 328.1 PG/ML.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E411 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : NA.
Additional Manufacturer Narrative
THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. AS THE ISSUE IMPROVED AFTER A NEW CALIBRATOR ALIQUOT WAS USED, THE ISSUE IS CONSISTENT WITH CALIBRATOR HANDLING AND/OR STORAGE ISSUES. NO GENERAL REAGENT ISSUE WAS FOUND.