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	Test Result (2695)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For 1 of the events, the investigation found from the information provided a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.There were no follow up actions.For 1 of the events, the investigation could not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.There were no follow up actions.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.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 elecsys tsh results were generated by a cobas 8000 e 602 module and a cobas 6000 e 601 module.The events involved a total of 2 patients the patients' ages ranged from 13 to 94 years.The patients' weights were requested but were not provided.The patients were both female.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
• MDR Report Key: 9991018
• Report Number: 1823260-2020-90077
• Device Sequence Number: 16663371
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• 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 Catalogue Number: 11731459122
• Device Lot Number: ASKU, 429091
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2020
• Patient Sequence Number: 1