ELECSYS IGE II
Received May 15, 2024 · Event occurred Apr 23, 2024
Report 1823260-2024-01454 · MDR key 19321624
Device
Generic name
Radioimmunoassay, Immunoglobulins (d,e)
Manufacturer
Roche DiagnosticsCatalog number
04827031190
Lot number
762905
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). THE CALIBRATION AND QC RESULTS WERE WITHIN SPECIFICATIONS. PREVENTIVE MAINTENANCE WAS PERFORMED AND THE SAMPLE/REAGENT PROBE AND SIPPER PROBE ADJUSTMENTS WERE CHECKED ALONG WITH THE BEAD MIXER FUNCTION, PHOTOMULTIPLIER HIGH VOLTAGE, BLANKCELL CALIBRATION AND PERFORMANCE TESTING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 0.931 IU/ML AND THE REPEAT RESULT WAS 589.9 IU/ML WITH A DATA FLAG.
Additional Manufacturer Narrative
DATA WAS PROVIDED FOR AN ADDITIONAL PATIENT SAMPLE WITH QUESTIONABLE ELECSYS IGE II RESULTS FROM THE COBAS E411 RACK ANALYZER. ON (B)(6) 2024, THE INITIAL RESULT WAS 1.04 IU/ML AND THE REPEAT RESULT WAS 14.74 IU/ML. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT PROBLEM WAS NOT PRESENT, BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES.