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

Model Number ADVIA CENTAUR XP

Device Problem False Negative Result (1225)

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

Event Date 03/30/2015

Event Type  malfunction  

Event Description

A discordant, false negative human chorionic gonadotropin (hcg) result was obtained on one patient sample on an advia centaur xp instrument.The discordant result was reported to the physician(s).A new sample was obtained from the patient and was tested on the same instrument, resulting positive.The original sample was repeated on an alternate advia centaur xp instrument, also resulting positive.The corrected result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, false negative hcg result.

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site and evaluated the instrument.The cse ran a total service call but could not find any instrument malfunction.The cse adjusted probe alignments and ran precision testing using the discordant patient sample, with acceptable results.The cse noticed a small fibrin strand in the patient sample and determined that the system had logged a sample integrity error at the time of the first run.The cause of a discordant, false negative hcg result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• 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: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 4731766
• MDR Text Key: 5586481
• Report Number: 2432235-2015-00215
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2013
• 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: 37 YR