MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY TEST

Catalog Number	08496633190
Medical Device Problem Code	Precipitate in Device or Device Ingredient (1478)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys anti-tshr on a cobas e 801 analytical unit.The customer stated they started noticing issues with the elecsys anti-tshr pre-treatment reagent as precipitates/crystals were observed in the working solution even after 75 minutes of rotation on a roller mixer.The issue was also noticed with a second reagent lot (lot 801939), but there was no impact on patient data using this lot.During the use of reagent lot 76926902, the reagent pack had to be recalibrated since the first control level recovered high.Patient samples run before the re-calibration were repeated after re-calibrating.One patient sample had discrepant anti-tshr results.No questionable results were reported outside of the laboratory.The user repeated the patient sample since approximately 70 % of patient samples usually result in values of < 0.8 iu/l.This sample initially resulted in an anti-tshr value of 3.4 iu/l.After re-calibration, the sample resulted in a value of 2.5 iu/l.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.Medwatch field e1 facility (b)(6).
Additional Manufacturer Narrative
Calibration and controls were acceptable prior to the event.The provided data showed that some level 1 control results were outside of range.Measurements for the in-use stability showed very good recovery of controls and samples over the measuring range.During the analysis intended to isolate crystals observed in the reagent, it was discovered that there were no crystals actually present.What appeared to be crystals in the reagent are, in fact, tiny air bubbles.The tiny bubble-like formations are due to the silicone surface of the bottle interacting with the glycerin in the solution.The air bubbles can be easily removed by gently swaying the reagent bottle.All lyophilized components of the reagent dissolve completely during the 60 minutes of continuous gentle agitation with a rotator, and therefore there is no issue.The non-reproducible results can be explained by the high imprecision in the lower measuring range.The investigation could not identify a product problem.

• Brand Name: ELECSYS ANTI-TSHR
• Common Device Name: THYROID AUTOANTIBODY TEST
• 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: 20014958
• Report Number: 1823260-2024-02398
• Device Sequence Number: 4343744
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K193313
• 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): 04/30/2025

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: 05/31/2025
• Device Catalogue Number: 08496633190
• Device Lot Number: 76926902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 04/30/2025
• 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