MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	TSH
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigations found for 2 of the events: the investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up actions for 2 of the events.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 2 malfunction events.Questionable non-reproducible results were generated by the elecsys tsh assay.The events involved a total of 11 patients tested on a cobas 8000 e 602 module and 2 cobas e 601 analyzers.The patients' ages were requested, but were not provided.The patients' weights were requested, but were not provided.The patients' genders were requested, but were not provided.The patients' races were requested, but were not provided.The patients' ethnicities were requested, but were not provided.

• Brand Name: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9238190
• Report Number: 1823260-2019-90257
• Device Sequence Number: 16663876
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: TSH
• Device Lot Number: ASKU
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2019
• Patient Sequence Number: 1