MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TG II; THYROGLOBULIN TEST SYSTEM

Catalog Number	08906564190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys tg ii on a cobas e 801 module.The results did not compare to competitor test results.The sample resulted in a tg value of 96.2 ng/ml (reference range = 3.5 - 7.7 ng/ml) when tested on the e801 analyzer with reagent lot number 702150.The sample was repeated on the e801 analyzer using reagent lot number 730633, resulting in a tg value of 98.2 ng/ml.The plasma tube of the same sample was repeated on the e801 analyzer using reagent lot number 730633, resulting in a tg value of 91.1 ng/ml.The sample was repeated using two different competitor methods.With the first method, the tg result was < 0.14 ng/ml.With the second method, the tg result was 0.13 ng/ml.Both competitor values are within their respective normal reference ranges.The customer deemed the competitor's results to be correct.
Additional Manufacturer Narrative
The e801 analyzer serial number is (b)(6).The first competitor method is the abbott architect.The second competitor method is an unknown radioimmunoassay (ria).The investigation is ongoing.
Additional Manufacturer Narrative
The provided quality control data was within range.A sample from the patient was requested for investigation, but one could not be provided.Per product labeling: "tg determinations can be affected by the presence of tg autoantibodies causing false high or false low tg values.Therefore anti tg determinations are recommended for all tg samples to rule out this interference." the investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TG II
• Common Device Name: THYROGLOBULIN TEST SYSTEM
• 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: 18516838
• Report Number: 1823260-2024-00144
• Device Sequence Number: 12450284
• Product Code: MSW
• UDI-Device Identifier: 07613336169582
• UDI-Public: 07613336169582
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: K221890
• 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): 02/02/2024

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: 08906564190
• Device Lot Number: 702150, 730633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/02/2024
• 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