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

Model Number	TSH
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
For 1 event, the investigation did not identify a product problem as no sample from the patient could be provided.The cause of the event could not be determined.From the provided information, a general reagent issue could most likely be excluded.For 1 event, the investigation did not identify a product problem.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 follow up actions for 2 events was that the sample was requested for investigation.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 low results were generated by the elecsys tsh assay on 2 cobas 6000 e601 modules.The events involved a total of 2 patients.The patients' ages ranged from "20's" years to 82 years.The patients' weights were requested but were not provided.There was 1 female and 1 male.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: 9996229
• Report Number: 1823260-2020-90075
• Device Sequence Number: 3321088
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2020
• Patient Sequence Number: 1