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

Catalog Number 07026919190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event 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).

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
• Type of Device: 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
• MDR Text Key: 280601538
• Report Number: 1823260-2021-03225
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630939619
• UDI-Public: 04015630939619
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female