MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FSH; RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

Catalog Number	11775863122
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6) the investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys fsh assay result for a patient sample tested on a cobas e 411 analyzer (disk system).The initial result was <0.300 miu/ml.The repeat result was 6.80 miu/ml.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The case of the event could not be determined due to the limited information provided.

• Brand Name: ELECSYS FSH
• Common Device Name: RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE
• 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: 24005335
• Report Number: 1823260-2026-00108
• Device Sequence Number: 18445453
• Product Code: CGJ
• UDI-Device Identifier: 04015630909223
• UDI-Public: 04015630909223
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K964693
• 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): 03/27/2026

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 11775863122
• Device Lot Number: 62576501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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