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

Catalog Number	08496609190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of cobas 1 is (b)(6), the serial number of cobas 2 is (b)(6).The elecsys anti-tshr reagent lot number is 801930.The expiration date was requested but not provided.The field service engineer (fse) inspected cobas 1 and verified that it is performing according to specifications.The fse inspected the cobas 2 and cleaned the probe and liquid flow channel (lfc) based on precision check results.The precision check results improved after cleaning.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys anti-tshr results from three patient samples tested on two cobas e411 rack analyzers (cobas 1 and cobas 2).The reporter stated that the analyzers' results would stray across the cutoff value, resulting in a positive result from the initial run and a negative result from the rerun.One patient sample with discrepant results was provided: the reporter was unable to provide the specific date for the event and only stated that the event was in the past.The initial result from cobas 1 was 2.2 iu/l.The repeat result from cobas 2 was 1.6 iu/l.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 contact office - manufacturing site and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the qc results; the qcs were within the specified ranges.The investigation determined that the event was consistent with the customer's frequent sample freeze/thaw cycles, which affected the concentration of the analyte, as well as the overall condition of cobas 2 (precision checks improved after liquid flow cleaning).A general reagent issue can be excluded.

• Brand Name: ELECSYS ANTI-TSHR
• Common Device Name: THYROID AUTOANTIBODY IMMUNOLOGICAL 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: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21761363
• Report Number: 1823260-2025-00990
• Device Sequence Number: 8455809
• Product Code: JZO
• UDI-Device Identifier: 07613336160305
• UDI-Public: 07613336160305
• Combination Product (Y/N): N
• 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): 08/11/2025

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 Catalogue Number: 08496609190
• Device Lot Number: 801930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 08/11/2025
• 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