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

Model Number ADVIA CENTAUR XP

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

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

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the event.

Event Description

Discordant, falsely depressed human chorionic gonadotropin results were obtained on a patient sample on an advia centaur xp instrument.The initial result was not reported out to the physician(s).The customer repeated the same sample, on the same advia centaur xp instrument, on dilution (1/100), resulting lower.The customer repeated the same sample on an alternate advia centaur instrument, on dilution (1/100), resulting higher.The customer repeated the same sample on the original advia centaur xp instrument, on dilution (1/100), resulting lower.The customer reported out the alternate instrument's result out to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed human chorionic gonadotropin results.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; registration number: 8020888; chapel lane; swords, co, dublin ; EI
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6517431
• MDR Text Key: 73570962
• Report Number: 2432235-2017-00287
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K971418
• 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
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2012
• 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