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

Model Number PROLACTIN G2

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigations for the 1 event did not identify a product problem.The cause of the event could not be determined.The patient sample was requested for investigation but was not provided.The follow up/corrective actions for the 1 event were as follows: the patient sample was run on a competitor system.A manual dilution was performed and the sample was checked for hemolysis.Calibration and qc were acceptable.No instrument issues were detected.The results for other patients were normal.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.An erroneous low result was generated by the cobas 6000 e 601 module.The events involved a total of 1 patient with the following: a low prolactin result.The patient's age was (b)(6).The patient's gender was female.

• Brand Name: ELECSYS PROLACTIN ASSAY
• Type of Device: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8549741
• MDR Text Key: 143415193
• Report Number: 1823260-2019-90089
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PROLACTIN G2
• Device Lot Number: 30128002
• Type of Device Usage: N
• Patient Sequence Number: 1