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

Catalog Number	07026919190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys anti-tg assay on a cobas 8000 e 801 module used for investigation.The sample results were reported outside of the laboratory.Data from other samples collected from the same patient have been previously reported in mfg report numbers 1823260-2020-01065 and 1823260-2020-01066.The sample was provided for investigation where it was tested on the e 801 analyzer, resulting in a value of 30.3 iu/ml (reference range = < 30 iu/ml).The sample was repeated on an abbott architect analyzer, resulting in a value of 2.04 iu/ml (reference range = < 4.11 iu/ml).The serial number of the e 801 analyzer is (b)(4).
Additional Manufacturer Narrative
If the results of auto-antibody assays (such as anti-tg) are compared, special care needs to be taken as the results may differ.It is known that different assays may generate different results, caused by the differences of the auto-antibodies measured by different assay formats.The investigation could not identify a product problem.

• Brand Name: ROCHE ELECSYS ANTI-TG
• Common Device Name: THYROID AUTOANTIBODY TEST SYSTEM
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12758225
• Report Number: 1823260-2021-03225
• Device Sequence Number: 3333019
• Product Code: JZO
• UDI-Device Identifier: 04015630939619
• UDI-Public: 04015630939619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053426
• Number of Events Summarized: 1
• Summary Report (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): 12/30/2021

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: 09/30/2022
• Device Catalogue Number: 07026919190
• Device Lot Number: 564501
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/30/2021
• 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 Age: 26 YR
• Patient Sex: Female