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 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse checked the probe alignment and found that the sample probe connector was loose.The cse replaced the sample probe and performed sample probe pressure test, which was acceptable.The cse also ran quality controls and patient samples.The cause of the discordant ferritin, folate and vitamin b12 results on multiple samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant ferritin (ferr), folate (fol) and vitamin b12 (vb12) results were obtained on multiple patient samples on an advia centaur xp instrument.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument, resulting different from the initial results.The repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant ferritin, folate and vitamin b12 results.

Manufacturer Narrative

The initial mdr 2432235-2015-00411 was filed on september 23, 2015.Additional information (09/15/2015): upon a follow-up visit, a siemens customer service engineer (cse) specialist found microbubbles at the wash manifold line and suspected micro leak at the connectors.The cse replaced the reagent probe 1, the reagent probe 2 and the wash displacement line at the manifold.The cse ran calibrations and quality controls, which were acceptable.A siemens headquarters support center (hsc) specialist reviewed the service report and indicated that the cause of the discordant ferritin, folate and vitamin b12 results on multiple samples was related to a malfunction of the manifold connectors.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, dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5091620
• MDR Text Key: 26482430
• Report Number: 2432235-2015-00411
• Device Sequence Number: 0
• Product Code: DBF
• 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
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• 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: 09/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2008
• 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