MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR; ANTI-TSHR IMMUNOASSAY

Model Number	ANTI-TSHR
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up actions.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.Discrepant low results were generated by two cobas 8000 e 801 modules.The events involved a total of 1 patient with the following: one sample with discrepant results for the elecsys anti-tshr immunoassay.
Additional Manufacturer Narrative
The initial report was incorrectly submitted as a summary report for an ineligible product code.

• Brand Name: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Common Device Name: ANTI-TSHR IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8830154
• Report Number: 1823260-2019-90166
• Device Sequence Number: 19466482
• Product Code: JZO
• UDI-Device Identifier: 04015630939954
• UDI-Public: 04015630939954
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: ANTI-TSHR
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/19/2019
• Patient Sequence Number: 1