MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PTH IMMUNOASSAY; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Model Number	PTH
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 investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up actions.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 1 malfunction event.Discrepant high results were generated by a cobas e 411 immunoassay analyzer.The events involved a total of 2 patients with the following: two samples with discrepant results for the elecsys pth immunoassay.One patient's gender was female.

• Brand Name: ELECSYS PTH IMMUNOASSAY
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8830161
• Report Number: 1823260-2019-90174
• Device Sequence Number: 16830036
• Product Code: CEW
• UDI-Device Identifier: 04015630939954
• UDI-Public: 04015630939954
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• 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: PTH
• Device Lot Number: 34169301
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1