MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HGH ASSAY; HUMAN GROWTH HORMONE ASSAY

Model Number	HGH
Medical Device Problem Code	Non Reproducible Results (4029)
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/corrective actions for this 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 1 malfunction event.Non-reproducible results were generated by the cobas 6000 e 601 module or the cobas 8000 e 602 module.The event involved a total of 2 patients tested for elecsys hgh.The patients' ages ranged from 56 - 64 years.There was 1 male and 1 female.

• Brand Name: ELECSYS HGH ASSAY
• Common Device Name: HUMAN GROWTH HORMONE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549729
• Report Number: 1823260-2019-90133
• Device Sequence Number: 1667034
• Product Code: CFL
• UDI-Device Identifier: 04015630926664
• UDI-Public: 04015630926664
• 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

• Operator of Device: No Information
• Device Model Number: HGH
• Device Lot Number: 286645
• 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