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

Model Number ADVIA CENTAUR XP

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse replaced the 3-way valves and the fluid input/output board (giob).Quality controls run subsequently were within the acceptable ranges.As per advia centaur xp_total hcg instructions for use "if the quality control results do not fall within the expected values or within the laboratory's established values, do not report results".The cause of the discordant results being reported to the physician(s) was due to the failure to follow instructions.The cause of the discordant thcg results on multiple patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant total human chorionic gonadotropin (thcg) results were obtained on multiple patient samples on an advia centaur xp instrument.The customer was running the patient samples while the quality controls were out of range.The discordant results were reported to the physician(s), who questioned them.The samples were repeated with different results from the initial results.The corrected results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant thcg results.

• 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, dublin ; EI
• Manufacturer Contact: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 5009784
• MDR Text Key: 25635433
• Report Number: 2432235-2015-00366
• Device Sequence Number: 0
• Product Code: DHA
• 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,u
• Reporter Occupation: Health Professional
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• 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: 07/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2013
• 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