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

Catalog Number	08932352190
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	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The afp reagent lot number was 821474.The expiration date was not provided.The cobas e411 disk serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys afp assay and 1 patient sample tested with elecsys fsh assay on a cobas e411 immunoassay analyzer (disk system).This medwatch will apply to the fsh assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the afp assay.Patient 1: afp: initial result: 0.750 iu/ml (accompanied by a data flag).Repeat result: 51.95 iu/ml.Patient 2 was tested on (b)(6) 2025: fsh: initial result: 0.300 miu/ml.Repeat result: 6.20 miu/ml.
Additional Manufacturer Narrative
The sample for patient 2 was repeated for a 2nd time for fsh on (b)(6) 2025, and the 2nd repeat result was 4.5 miu/ml.No calibration influence was observed.The provided qc was not within expectations for the day of the event.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 23096281
• Report Number: 1823260-2025-03186
• Device Sequence Number: 18334471
• 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): 11/07/2025

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: 03/31/2026
• Device Catalogue Number: 08932352190
• Device Lot Number: 813861
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/07/2025
• 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