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

Model Number ADVIA CENTAUR XPT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.The customer stated that when the sample in question was repeated on the advia centaur xpt instrument, the results were as expected.The customer also ran two known samples for total hcg, which matched the initial runs.Quality controls were within acceptable range.The cause of the discordant, falsely elevated total hcg result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated total human chorionic gonadotropin (total hcg) result was obtained on one patient sample on an advia centaur xpt instrument.The discordant result was reported to the physician(s).The patient went to an emergency department as she was having vaginal bleeding.The emergency department performed total hcg testing for the patient on an alternate platform and the result was negative for total hcg.The physician(s) questioned the initial result obtained on the advia centaur xpt instrument.The customer repeated the sample twice on the original advia centaur xpt instrument, resulting lower both times.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated total hcg result.

Manufacturer Narrative

The initial mdr 2432235-2017-00526 was filed on september 27, 2017.Additional information (10/31/2017): a siemens headquarters support center specialist reviewed the event data and stated that this was an isolated event.If there was a system issue at the time of the discordant result, there were no indications that a system problem existed and quality controls were within specification.The cause of the discordant, falsely elevated total human chorionic gonadotropin result on one patient sample is unknown.

• Brand Name: ADVIA CENTAUR XPT
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 6898012
• MDR Text Key: 88252706
• Report Number: 2432235-2017-00526
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K141999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XPT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 36 YR