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

Catalog Number	08932352190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 disk serial number was (b)(6).The field service engineer found that the bead mixture was creating bubbles in the microbeads compartment in the reagent.He replaced the bead mixture shaft and adjusted the mixer speed.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys fsh results from the cobas e411 disk analyzer.Patient 1 initial result was < 0.300 miu/ml with a data flag, and the repeat result was 36.25 miu/ml.Patient 2 initial result was < 0.300 miu/ml with a data flag, and the repeat result was 7.5 miu/ml.
Additional Manufacturer Narrative
The investigation determiend that the service actions resolved the issue.

• 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: 24956933
• Report Number: 1823260-2026-01547
• Device Sequence Number: 5264857
• Product Code: CGJ
• UDI-Device Identifier: 07613336170373
• UDI-Public: 07613336170373
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• 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): 05/11/2026

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: 08932352190
• Device Lot Number: 871044
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/11/2026
• 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 Age: 34 YR
• Patient Sex: Female