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

Catalog Number	07026919190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's calibration and qc results, sample pre-analytic details, and system alarm trace were requested but not provided.Per product labeling, "the measured anti-tg value of a patient's sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the anti-tg assay method used.Anti-tg values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.If there is a change in the anti-tg assay procedure used while monitoring therapy, then the anti-tg values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods." based on the available information, a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter received questionable roche elecsys anti-tg results for one patient tested on a cobas 8000 e 801 module.The e 801 module serial number was requested but not provided.The patient's initial elecsys anti-tg result was not reported outside the laboratory.The customer provided the patient's sample for further investigation and the sample was tested on a cobas 8000 e 801 module and an abbott architect.Refer to the attachment on the medwatch for all patient data.

• 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: 12810450
• Report Number: 1823260-2021-03356
• Device Sequence Number: 4778293
• 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
• Report Date (Section B): 11/15/2021

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 Catalogue Number: 07026919190
• Device Lot Number: ASKU
• 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: 10/26/2021
• Initial Report FDA Received Date: 11/15/2021
• 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 Sex: Unknown