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	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-tshr immunoassay results from 7 patients on a cobas e 801 module.The customer reported that there is a result discrepancy between 2 reagent lots.On (b)(6) 2022, sample 1's result from lot 566091 was 2.5 iu/l.The result from lot 62838001 was 1.4 iu/l.The second result from lot 62838001 after re-calibration was 1.7 iu/l.On (b)(6) 2022, sample 2's result from lot 566091 was 2.6 iu/l.The result from lot 62838001 was 1.5 iu/l.The second result from lot 62838001 after re-calibration was 1.6 iu/l.On (b)(6) 2022, sample 3's result from lot 566091 was 2.3 iu/l.The result from lot 62838001 was 1.6 iu/l.On (b)(6) 2022, sample 4's result from lot 566091 was 2.2 iu/l.The result from lot 62838001 was 1.5 iu/l.On (b)(6) 2022, sample 5's result from lot 566091 was 2.3 iu/l.The result from lot 62838001 was 1.6 iu/l.On (b)(6) 2022, sample 6's result from lot 566091 was 2.5 iu/l.The result from lot 62838001 was 1.8 iu/l.On (b)(6) 2022, sample 18's result from lot 566091 was 2.27 iu/l.The first result from lot 62838001 was 1.5 iu/l and the second result was 2.03 iu/l.No questionable results were reported outside of the laboratory.It is unknown which results were deemed correct.The expiration date for reagent lot 566091 was requested but not provided.The analyzer serial number was requested but not provided.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined that the complained reagents' lot numbers had acceptable recovery using qc and native patient samples.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15654275
• Report Number: 1823260-2022-03296
• Device Sequence Number: 5965851
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• 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): N
• 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): 03/16/2023

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: 09/30/2023
• Device Catalogue Number: 08496633190
• Device Lot Number: 62838001, 566091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 03/16/2023
• 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