MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROLACTIN ASSAY; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Model Number	PROLACTIN G2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation stated the patient was taking very high dosages of biotin.The issue observed is consistent with interference caused by biotin intake.The patient sample was not available for further investigation, therefore, the cause of the event could not be determined.The investigation did not identify a product problem.The follow up/corrective action was that the sample was requested for investigation but could not be provided.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.Low results were generated by the cobas 8000 e 602 module.The event involved 1 patient with low results for the elecsys prolactin assay.The patient's age was requested, but was not provided.The patient's weight was requested, but was not provided.The patient's gender was requested, but was not provided.The patient's race was requested, but was not provided.The patient's ethnicity was requested, but was not provided.

• Brand Name: ELECSYS PROLACTIN ASSAY
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8280772
• Report Number: 1823260-2019-90042
• Device Sequence Number: 19437673
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• 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: PROLACTIN G2
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2019
• Patient Sequence Number: 1