MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number	06368590190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 disk serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable anti-tpo elecsys results from the cobas e411 disk analyzer.Patient 1 initial result was 152.5 iu/ml with a data flag.The repeat result on another cobas e411 was 50.68 iu/ml with a data flag and reported outside of the laboratory.The repeat result on the original analyzer was 48.68 iu/ml with a data flag.Patient 2 initial result was 151.2 iu/ml with a data flag.The repeat result on another cobas e411 was 11.54 iu/ml and reported outside of the laboratory.The repeat result on the original analyzer was 13.57 iu/ml.Patient 3 initial result was 341.7 iu/ml with a data flag.The repeat result on another cobas e411 was 19.91 iu/ml and reported outside of the laboratory.The repeat result on the original analyzer was 23.20 iu/ml with a data flag.Patient 4 initial result was 131.4 iu/ml with a data flag.The repeat result on another cobas e411 was 59.11 iu/ml with a data flag and reported outside of the laboratory.The repeat result on the original analyzer was 69.04 iu/ml with a data flag.
Additional Manufacturer Narrative
The field service engineer replaced micro-particle stirrer (bead mixer) due to the higher generation of foam in the reagent.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS ANTI-TPO
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 18282355
• Report Number: 1823260-2023-03888
• Device Sequence Number: 14963402
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• PMA/510(K) Number: K051890
• 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): 12/22/2023

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: 02/29/2024
• Device Catalogue Number: 06368590190
• Device Lot Number: 70815802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/22/2023
• 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