MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ESTRADIOL III ASSAY; RADIOIMMUNOASSY, ESTRADIOL

Catalog Number	06656021190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 disk serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys estradiol iii assay results from fifteen patient samples tested on the cobas e 411 analyzer (disk system).The following examples of discrepant results for three patient samples were provided: patient sample 1.The initial result is >3000 pg/ml.The first repeat result at 1:10 dilution is 1205 pg/ml.The second repeat result of the undiluted patient sample is 2916 pg/ml.The third repeat result at 1:10 dilution is 1279 pg/ml.The fourth repeat result of the undiluted patient sample from a new reagent pack with improved calibration and qc is 1601 pg/ml.This result was deemed correct by the nursing staff.Patient sample 2.The initial result is >3000 pg/ml.The first repeat result at 1:10 dilution is 1805 pg/ml.The second repeat result of the undiluted patient sample is >3000 pg/ml.The third repeat result at 1:10 dilution is 1773 pg/ml.The fourth repeat result of the undiluted patient sample from a new reagent pack with improved calibration and qc is 2524 pg/ml.This result was deemed correct by the nursing staff.The fifth repeat result at 1:10 dilution is 1717 pg/ml.Patient sample 3.The initial result is >3000 pg/ml.The first repeat result at 1:10 dilution is 7111 pg/ml.The second repeat result of the undiluted patient sample from a new reagent pack with improved calibration and qc is >3000 pg/ml.The third repeat result at 1:10 dilution is 5304 pg/ml.This result was deemed correct by the nursing staff.The reporter verifies results <2400 pg/ml.
Additional Manufacturer Narrative
The field service engineer found that the photomultiplier (pmt) high voltage needed to be adjusted.He performed the adjustment and ran performance testing and precision testing, which were acceptable.The customer ran qc, which was acceptable.Operational and/or mechanical checks passed.There was no indication of a general performance issue with the reagent, as qc recovery was within the customer's established ranges.No relevant alarms were observed in the analyzer alarm trace near the time of the event.The investigation was unable to determine a specific root cause.

• Brand Name: ELECSYS ESTRADIOL III ASSAY
• Common Device Name: RADIOIMMUNOASSY, ESTRADIOL
• 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: 23393331
• Report Number: 1823260-2025-04364
• Device Sequence Number: 10179228
• Product Code: CHP
• UDI-Device Identifier: 04015630933358
• UDI-Public: 04015630933358
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K965109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 01/31/2026
• Device Catalogue Number: 06656021190
• Device Lot Number: 84459400
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/17/2025
• 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 Age: 38 YR
• Patient Sex: Female