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

Catalog Number	07027249190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys estradiol iii results for 2 samples from the cobas e 801 module.Sample 1 initial result was <0.6 pmol/l.The repeat result using the same analyzer was 480 pmol/l.The repeat results from another e801 analyzer were 14.9 pmol/l, 14.3 pmol/l, 11010 pmol/l, and 24013 pmol/l.Sample 2 initial result was 2559 pmol/l.The repeat results from another e801 analyzer were 11010 pmol/l, 11010 pmol/l, 11010 pmol/l, and 25168 pmol/l.
Additional Manufacturer Narrative
The investigation was unable to determine a specific root cause.The analyzer alarm trace contained "sample short", "reagent probe", and "sample foam" alarms on the day of the event.Based on these alarms, pre-analytical handling issues at the customer site could not be excluded.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• 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: 24307433
• Report Number: 1823260-2026-00460
• Device Sequence Number: 14781056
• Product Code: CHP
• UDI-Device Identifier: 04015630939671
• UDI-Public: 04015630939671
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/28/2026

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: 858567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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