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

Model Number	PTH
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 1 malfunction events.Erroneous elecsys pth immunoassay results were generated.The events involved a total of 9 patients.The patients' ages were requested but were not provided.The patients' weights were requested but were not provided.The 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
Samples from the patient were provided for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.The results obtained with the elecsys pth immunoassay were considered to be correct.The observed variations in pth results was most likely due to the specific clinical picture of the patient.

• 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: 8285292
• Report Number: 1823260-2019-90070
• Device Sequence Number: 1953278
• Product Code: CEW
• UDI-Device Identifier: 04015630939237
• UDI-Public: 04015630939237
• 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,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: PTH
• Device Lot Number: 30266603
• 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