MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XPT

Device Problems Device Issue (2379); Device Handling Problem (3265)

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

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The ccc specialist was informed that their alternate instrument was also set with a dilution point of 10, and stated that no samples were falsely diluted.The laboratory has a centralink and has an existing dilution trigger associated with ca 15-3 were all samples that generate a "> dilution point" flag and ">450" will be auto-reflexed for a 1/10 dilution.Ca 15-3 patient sample testing was stopped on the instrument and testing was forwarded to a different laboratory.Siemens is investigating.This event is associated with the following mdrs: 2432235-2018-00267, 2432235-2018-00268, 2432235-2018-00269, 2432235-2018-00270, 2432235-2018-00271, 2432235-2018-00273, 2432235-2018-00274, 2432235-2018-00275, 2432235-2018-00276.

Event Description

The customer informed siemens that ca 15-3 patient samples were falsely diluted on the advia centaur xpt instrument.Upon review, the customer noticed an incorrect dilution point of 10 had been set in the test definition under the ranges tab and the instrument performed unnecessary auto-dilutions.The diluted patient results were reported via the laboratory information system (lis) and were not questioned by the physician(s).The customer did not perform repeat testing.On (b)(6) 2018, discordant results that were reported were amended to the undiluted value/correct value.There are no known reports of patient intervention or adverse health consequences due to the falsely diluted ca 15-3 patient sample results.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2018-00272 on 25-june-2018.Additional information (27-september-2018): siemens has evaluated the event, and the issue is solved.The customer has removed the incorrect dilution setting from the advia centaur xpt instrument and decided not to run (b)(6) patient sample testing on the instrument.The customer has been unable to provide additional details regarding the results obtained on april 2018.The cause for (b)(6) patient samples to be falsely diluted on the advia centaur xpt instrument is due to the operator and a use error.No further evaluation of the device is required.The following mdrs are filed for the same event: 2432235-2018-00266, 2432235-2018-00267, 2432235-2018-00268, 2432235-2018-00269, 2432235-2018-00270, 2432235-2018-00271, 2432235-2018-00273, 2432235-2018-00274, 2432235-2018-00275, 2432235-2018-00276.

• Brand Name: ADVIA CENTAUR XPT
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7636157
• MDR Text Key: 112764782
• Report Number: 2432235-2018-00272
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: 00630414596914
• Combination Product (y/n): N
• PMA/PMN Number: K141999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XPT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1