ELECSYS IGE II
Received Apr 21, 2025 · Event occurred Mar 30, 2025
Report 1823260-2025-01211 · MDR key 21876330
Device
Generic name
Radioimmunoassay, Immunoglobulins (d, E)
Manufacturer
Roche DiagnosticsCatalog number
07027516214
Lot number
826681
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 SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS IGE II ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN IGE VALUE OF 7.75 IU/ML. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER ON (B)(6) 2025, RESULTING IN AN IGE VALUE OF 1037 IU/ML. THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER ON (B)(6) 2025, RESULTING IN AN IGE VALUE OF 1038 IU/ML.
Additional Manufacturer Narrative
NO CALIBRATION INFLUENCE WAS OBSERVED. QUALITY CONTROLS WERE WITHIN RANGE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. A REVIEW OF ALARM TRACE DATA SHOWED NO ABNORMALITIES AROUND THE TIME OF THE EVENT. A FEW SAMPLES QUALITY RELATED ALARMS WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.