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

Model Number ADVIA CENTAUR XP

Device Problem Mechanical Problem (1384)

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

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist and stated that their quality controls were out of ranges.A siemens customer service engineer (cse) specialist was dispatched to the customer site.The cse evaluated the instrument and performed a total service call.The cse inspected the probes, checked the calibrations and dispenses and replaced the reagent probe 1.The cse then inspected and cleaned the wash stations, checked the port dispenses and replaced the aspirate wash guides.The cse also cleaned the aspirate and water lines with bleach, inspected the fittings of the manifolds, diluters, pumps and tubings and ran quality controls, which were acceptable.The cause of the discordant, falsely elevated ferritin 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 ferritin (ferr) result was obtained on one patient sample upon repeat testing on an advia centaur xp instrument.The sample was initially run on the same instrument, resulting lower.The initial and repeat results were not reported to the physician(s).The sample was repeated on the same instrument for the second time, which resulted lower than the first repeat result and matched the initial result.The second repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ferritin result.

• 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: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6069409
• MDR Text Key: 58851447
• Report Number: 2432235-2016-00671
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/01/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2013
• 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