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
The investigations for all 12 events could not identify a product problem.The cause of the events could not be determined.There were no follow up/corrective actions for all 12 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 12 malfunction events.Erroneous high results were generated by seven cobas 6000 e 601 modules, a cobas 6000 core unit, two cobas 8000 e 602 modules, two cobas e 411 immunoassay analyzers, and two cobas 8000 e 801 module analyzers the events involved a total of 13 patients with the following: erroneous test results for fifteen samples tested with the elecsys tsh assay.Eight patients' ages ranged from (b)(6) to (b)(6).There were 5 females and 3 males.

• 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: 8549730
• Report Number: 1823260-2019-90126
• Device Sequence Number: 2256784
• 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, 34169903, 354268
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1