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

Model Number	PTH
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigations found that an instrument problem was not observed.The customer believes the issue was due to a single reagent pack that was replaced following the event.The customer has had no further issues since replacing the reagent pack.The investigation did not identify a product problem.The cause of the event could not be determined.The follow up/corrective actions were that the field service engineer performed a photomultiplier voltage adjustment.Analyzer performance testing was completed.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 events.Erroneous low results were generated by the cobas e 411 immunoassay analyzer.The event involved a total of 26 patients with erroneous results for elecsys pth immunoassay.The patients' ages were requested but were not provided.The patients' weights were requested but were not provided.There 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.

• 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: 8281625
• Report Number: 1823260-2019-90007
• Device Sequence Number: 16452412
• Product Code: CEW
• UDI-Device Identifier: 04015630939237
• UDI-Public: 4015630939237
• 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: 302666
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2019
• Patient Sequence Number: 1