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

Catalog Number	07027249190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys estradiol iii results for 2 patient samples on a cobas e 801 analytical unit, a cobas e 602 module, and a cobas e 411 analyzer compared to 2 competitor analyzers.On (b)(6) 2025, the sample was tested twice on the e 801 analyzer and the results were 699 pmol/l and 712 pmol/l.On (b)(6) 2025, the sample was tested twice on a snibe maglumi analyzer and the results were 53.6 pmol/l and 64.1 pmol/l.On (b)(6) 2025, the sample was tested on the e 801 analyzer again and the result was 693 pmol/l.On (b)(6) 2025, the sample was sent to another laboratory and tested on an e 602 analyzer and the result was 662.8 pmol/l.On (b)(6) 2025, the same patient had a new sample collected and the initial result from the e 801 analyzer was 352 pmol/l.The sample was repeated and the result was 372 pmol/l.The sample was sent to another laboratory and tested on an e 411 analyzer and the result was 453.0 pmol/l.On (b)(6) 2025, the sample was tested on a snibe maglumi analyzer and the result was 33.5 pmol/l.The sample was also tested on an abbott alinity and the result was <88.1 pmol/l.
Additional Manufacturer Narrative
The e 801 analyzer serial number is (b)(6).The serial numbers of the e 602 and e 411 analyzers were requested, but not provided.The patient sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc recovery data provided was within specification.The patient sample was received for investigation and the customer's results were confirmed.No interfering factor was identified in the sample.Based on the qc data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS ESTRADIOL III
• 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: 23758943
• Report Number: 1823260-2025-05015
• Device Sequence Number: 10150384
• Product Code: CHP
• UDI-Device Identifier: 04015630939671
• UDI-Public: 04015630939671
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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 Catalogue Number: 07027249190
• Device Lot Number: 88756500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 04/01/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALPHA-LIPOIC ACID.; ASHWAGANDHA.; ASTRAGALUS.; BERBERINE.; BORON.; CZECH VIRUS KIDNEY MAX.; CZECH VIRUS LIVER MAX V2.0.; CZECH VIRUS SUPERVITA PRO 2.0.; CZECH VIRUS ZMA MAX.; DAA.; GYMNEMA SYLVESTRE.; MACA.; PROM-IN GLUCOSE CONTROL.; RESVERATROL.
• Patient Sex: Male