MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGE II IMMUNOASSAY; RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E)

Catalog Number	04827031190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: ELECSYS IGE II IMMUNOASSAY
• Common Device Name: RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23526047
• Report Number: 1823260-2025-04593
• Device Sequence Number: 16002990
• Product Code: JHR
• UDI-Device Identifier: 04015630922369
• UDI-Public: 04015630922369
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K061970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 04827031190
• Device Lot Number: 82669002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown