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 two events, the investigation did not identify a product problem.The cause of the event could not be determined.For three events, the investigation is ongoing.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 5 malfunction events.Erroneous low elecsys tsh assay results were generated.The events involved a total of 6 patients.The provided patients' ages ranged from (b)(6) to (b)(6).The other patients' ages were requested but were not provided.The patients' weights were requested but were not provided.The provided patient genders were 3 females.The other 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.
Additional Manufacturer Narrative
For the three remaining events, the investigation did not identify a product problem.The cause of the event could not be determined.Tsh assays from different manufacturers can generate different results.This relates to differences in assay set up, antibodies used, and differences in standardization procedures.

• 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: 8285619
• Report Number: 1823260-2019-90074
• Device Sequence Number: 1599129
• 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,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: TSH
• Device Lot Number: ASKU,331814,354268
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1