MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS E2G 300 V2; THYROID-STIMULATING HORMONE ASSAY

Catalog Number	08443432214
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tsh elecsys e2g 300 v2 results for 1 patient sample on a cobas e 801 module.Refer to the highlighted results in the attachment (b)(4) for patient results.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The sample (sample 1) was received for investigation on 06-mar-2024.The customer's elevated tsh results were confirmed.Upon investigation of the returned sample with a research version of the tsh assay with an alternative label structure (suru assay version), a significantly reduced value was generated: the investigation's result with the elecsys tsh reagent was 26.56 iu/ml.The investigation's result with suru tsh assay version was 0.39 iu/ml.A ruthenium interfering factor was found in the alleged sample causing falsely elevated values with the elecsys tsh reagent.This is a known interference clearly disclaimed in product labeling.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." a general product problem could be excluded.

• Brand Name: TSH ELECSYS E2G 300 V2
• Common Device Name: THYROID-STIMULATING HORMONE ASSAY
• 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: 18705840
• Report Number: 1823260-2024-00443
• Device Sequence Number: 14938436
• Product Code: JLW
• UDI-Device Identifier: 07613336193693
• UDI-Public: 07613336193693
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K190773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 08443432214
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEVOTHYROXINE.
• Patient Sex: Unknown