MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA CENTAUR XP

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 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer site.The cse inspected the system by performing a total service call.The acid and base pumps were dispensing correctly.The pinch valves were working correctly.Adjusted alignments for reagent probe 1 and sample probe, including tip to bottom of cuvette.Adjusted alignments for aspirate probes and checked aspiration; vacuum is ok.Qc is in range.System is operational.The cause of the discordant total hcg result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant falsely low total hcg result was obtained from an advia centaur xp system.The result was released to the physician who questioned the result.The initial sample was not available for retesting.The patient was redrawn at a later date and the sample was tested using an alternate system.This result was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant total hcg result.

Manufacturer Narrative

The initial mdr 2432235-2017-00286 was filed 24-apr-2017.Siemens healthcare diagnostics manufacturing (b)(4).

• Brand Name: ADVIA CENTAUR XP
• Type of Device: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10595
• MDR Report Key: 6516379
• MDR Text Key: 73568655
• Report Number: 2432235-2017-00286
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: 02/22/2018
• Supplement Dates FDA Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1