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

Model Number	TSH
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For 1 event, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.For 3 events, the investigation did not identify a product problem.The cause of the event could not be determined.Results generated with the different analyzers from different manufacturers, are caused by differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.For 1 event, the investigation is ongoing.The follow up action for 1 event was that the sample was requested for investigation but could not be provided.The follow up action for 1 event was that sample from the patient was submitted for investigation.The follow up action for 2 events was that sample from the patient was submitted for investigation.No interference could be identified.There were no follow up actions for 1 event.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.Questionable high results were generated by the elecsys tsh assay on 3 cobas 6000 e601 modules, 3 cobas e411 analyzers and a cobas 8000 e 602 module.The events involved a total of 5 patients.The patients' ages ranged from "teens" years to 49 years.The patients' weights were requested but were not provided.There were 5 females.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: 9996202
• Report Number: 1823260-2020-90076
• Device Sequence Number: 3321085
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 4015630899661
• Combination Product (Y/N): N
• Number of Events Summarized: 5
• 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 Lot Number: 42909101, 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