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

Catalog Number	06656021190
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys estradiol iii results from six patient samples tested on the cobas e 411 analyzer (rack system).Patient sample 1 the initial result was >3000 pg/ml.The repeat result at 1:10 dilution was 1884 pg/ml.Patient sample 2 the initial result was >3000 pg/ml.The repeat result at 1:10 dilution was 2031 pg/ml.Patient sample 3 the initial result was >3000 pg/ml.The repeat result at 1:10 dilution was 2505 pg/ml.Patient sample 4 the initial result was >3000 pg/ml.The repeat result at 1:10 dilution was 2506 pg/ml.Patient sample 5 the initial result was >3000 pg/ml.The repeat result at 1:10 dilution was 2245 pg/ml.Patient sample 6 the initial result was >3000 pg/ml.The repeat result at 1:10 dilution was 1717 pg/ml.The initial results were not reported outside of the laboratory, as multiple patient sample results of >3000 pg/ml, prompting the rerun.The repeat results were deemed correct, as they matched the results from another laboratory.
Additional Manufacturer Narrative
The cobas e 411 analyzer (rack system) serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc were acceptable.There was no indication of a reagent issue.The field service engineer (fse) found that the cause was due to an issue with the calibrator.He used a new calibrator and performed an assay performance check and performance testing, and they were within specifications.He also verified that unnecessary dilutions were reduced.The service engineer verified that the instrument was performing within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 23337480
• Report Number: 1823260-2025-04255
• Device Sequence Number: 18085367
• Product Code: CHP
• UDI-Device Identifier: 04015630933358
• UDI-Public: 04015630933358
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/23/2025

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: 844594
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 62 KG