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

Catalog Number	07027249190
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The estradiol iii reagent expiration date was not provided.The cobas e 801 analytical unit serial number was (b)(6) the investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 samples from the same patient tested with elecsys estradiol iii assay on a cobas e 801 analytical unit.Sample 1: initial result: 126 pg/ml.1st repeat result: 13.01 pg/ml (tested on abbott).2nd repeat result: 80.71 pg/ml (tested on roche e 602 at a different facility).Sample 2: on (b)(6) 2025: initial result: 139 pg/ml.1st repeat result: 19.5 pg/ml (tested on abbott).2nd repeat result: 104.3 pg/ml (tested on roche e 602 at a different facility).The initial results did not match the patient's clinical diagnosis, prompting the repeat of the samples.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
Medwatch field b7 other relevant history was updated.The patient's samples were received for investigation.The investigation was unable to reproduce the customer's elecsys estradiol iii results.The investigation tested the patient's samples for interferents and identified streptavidin and heterophilic antibody (igm) interferents.A general product problem can be excluded.The product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.The cause of the event was due to interferents in the patient's samples.

• 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: 24020151
• Report Number: 1823260-2026-00119
• Device Sequence Number: 8970260
• Product Code: CHP
• UDI-Device Identifier: 04015630939671
• UDI-Public: 04015630939671
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/09/2026

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: 85857800
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/09/2026
• 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
• Patient Sex: Unknown