ELECSYS IGE II IMMUNOASSAY
Received Nov 11, 2025 · Event occurred Oct 22, 2025
Report 1823260-2025-04593 · MDR key 23526047
Device
Generic name
Radioimmunoassay, Immunoglobulins (d,e)
Manufacturer
Roche DiagnosticsCatalog number
04827031190
Lot number
82669002
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
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS IGE II IMMUNOASSAY ON A COBAS 6000 E601 MODULE. THE SAMPLE INITIALLY RESULTED IN AN IGE VALUE OF 1573 IU/ML. THE SAMPLE WAS DILUTED 1:20 AND REPEATED, RESULTING IN A VALUE OF > 50000 IU/ML WITH A DATA FLAG.
Additional Manufacturer Narrative
THE E601 ANALYZER SERIAL NUMBER IS(B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
BASED ON THE PROVIDED QUALITY CONTROL DATA, A REAGENT ISSUE IS NOT INDICATED. THE AVAILABLE INFORMATION SUGGESTS THE PATIENT SAMPLE EXHIBITS EXTREMELY ELEVATED IGE CONCENTRATIONS > 50000 IU/ML. PER PRODUCT LABELING, THERE IS NO HIGH-DOSE HOOK EFFECT AT IGE CONCENTRATIONS UP TO 50000 IU/ML. THE DILUTED RESULT OF THE SAMPLE MEASURED IN 1:20 DILUTION RESULTED WITH VALUE >50000, WHICH IS ABOVE THE HIGH-DOSE HOOK EFFECT CLAIM. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH A HIGH-DOSE HOOK EFFECT OF THE SAMPLE DUE TO EXTREMELY ELEVATED IGE CONCENTRATIONS.