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 Consequences Or Impact To Patient (2199)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in fra.The customer performed additional testing to check for an interference with no success: the customer diluted the samples and the results were always low.Chromatography results were also low.Pure and diluted samples were sent to external laboratories for testing by the abbott method and the fujirebio method; the results were comparable to the roche results (low).Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of low results not corresponding to the clinical picture for 1 patient tested for elecsys prolactin ii (prolactin ii) on a cobas 6000 e 601 module.On (b)(6) 2020 the patient had a result of 96,900 miu/l.This result is believed to be correct.On (b)(6) 2020 the result from a new sample was 6.16 miu/l.On (b)(6) 2020 the result from a new sample was < 3.6 miu/l.It is not clear if any questionable results were reported outside of the laboratory.The customer suspects an interference affecting the results.The e601 module serial number was (b)(4).

• Brand Name: ELECSYS PROLACTIN ASSAY
• Type of Device: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10326507
• MDR Text Key: 200432248
• Report Number: 1823260-2020-01798
• Device Sequence Number: 1
• Product Code: CFT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROLACTIN G2
• Device Catalogue Number: 03203093190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NIVOLUMAB