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

Catalog Number	08932352190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The serial number for the other module was requested, but not provided.The sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys fsh assay results for 1 patient sample on a cobas e 411 analyzer (disk system).An interference with autoantibodies is suspected.The initial result was 64.7 miu/ml.The result using the clia method was 21.7 miu/ml.The result using the abbott method was 21.1 miu/ml.On (b)(6) 2024 the sample was tested on another module using the elecsys fsh assay and the result was 67.78 miu/ml.It was reported that peg (polyethylene glycol) precipitation testing was performed with the sample on another module and the "recovery rate of fsh was significantly reduced, and autoimmune ig-fsh complexes ("macro-fsh") were identified by gel filtration chromatography".Another peg (polyethylene glycol) precipitation test was performed on the sample using the abbott method and "the recovery rate of fsh dropped significantly.".The numerical values from the peg tests were not provided.
Additional Manufacturer Narrative
The alleged sample was returned for investigation.The investigation results show an interference of the patient sample caused by macro fsh.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.

• Brand Name: ELECSYS FSH ASSAY
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20853800
• Report Number: 1823260-2024-03525
• Device Sequence Number: 8839339
• Product Code: CGJ
• UDI-Device Identifier: 07613336170373
• UDI-Public: 07613336170373
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/23/2025

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 Catalogue Number: 08932352190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/23/2025
• 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