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

Catalog Number	08496633190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial numbers of the customer's cobas e 801 and e 402 analyzers were requested but not provided.The lot number of the anti-tshr reagent used in the customer's e 801 is 735662.The lot number of the anti-tshr reagent used in the customer's e 402 was not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys anti-tshr results from 20 patient samples tested on the cobas e 801 analytical unit, cobas 6000 e 601 module, and cobas pure e 402 analytical unit.This mdr is for the anti-tshr used in the e 801 and e 402 analyzers.Please refer to mdr with a1.Patient identifier (b)(6) for the anti-tshr used in the e 601 analyzer.The reporter stated that they changed their analyzer from a cobas e601 to a cobas e 801 and found that the anti-tshr results tended to be lower on the e 801.The reporter was not able to state which results were deemed correct.The clinician questioned the reason for the discrepancy.The reporter was able to provide seven patient samples with discrepant results.Please refer to the attachment (b)(6) for the table containing the highlighted questionable results.
Additional Manufacturer Narrative
The investigation reviewed the data from the cobas e 801 module, the cobas e 402 analytical unit, and the cobas e 601 module.The results from the cobas e 801 module and the cobas e 402 analytical were comparable; the results from the cobas e 601 were slightly higher.The investigation determined that the small difference was consistent with the overall position of the calibration curves of the analyzers, which may relate to the overall condition of the analyzers e.G.The measuring cell(s).The investigation excluded a general reagent issue.The investigation did 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: 18676218
• Report Number: 1823260-2024-00385
• Device Sequence Number: 7308832
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 03/25/2024

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: 08496633190
• Device Lot Number: 735662, 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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