MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	08443432190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e 801 analyzer is unknown.The tsh reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(6).Tsh reagent lot 714216, with an expiration date of 01-jul-2024 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(6).Tsh reagent lot 660341, with an expiration date of 31-aug-2023 was used on this analyzer.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable values for six patient samples tested with thyroid assays on two cobas e 801 module analyzers and a cobas e 411 analyzer.Results for the following assays were affected: elecsys tsh, elecsys ft4 iv, and elecsys ft3 iii.The specific date of the event is not known.This medwatch will cover the tsh assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft4 assay and refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft3 assay.Refer to the attachment for all patient data.The values highlighted in yellow were questioned.Samples were initially tested on the customer's e 801 analyzer on an unknown date.The samples were provided for investigation, where they were tested on a second e 801 analyzer and an e411 analyzer on (b)(6) 2023.The samples were repeated on an abbott architect analyzer on (b)(6) 2023.
Additional Manufacturer Narrative
Of the 6 patient samples, further investigations were performed with sample id (b)(6).Investigations of this sample determined that it contains an interfering factor against the streptavidin components of the ft3 and ft4 assays.Per product labeling, "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 all other samples and for tsh values of sample id (b)(6), the difference in results relates to differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.

• Brand Name: ELECSYS TSH
• Common Device Name: RADIOIMMUNOASSAY, THYROID-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: 17785465
• Report Number: 1823260-2023-03032
• Device Sequence Number: 20552010
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K961491
• 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): 01/02/2024

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: 08443432190
• Device Lot Number: ASKU, 714216, 660341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 01/02/2024
• 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
• Patient Sex: Unknown