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

Model Number ADVIA CENTAUR XP

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

Discordant, (b)(6) results were obtained on four patient samples on a advia centaur xp instrument.The initial (b)(6) results were reported to the physician(s), who questioned them.Three samples were repeated two times on the same system, resulting (b)(6).One patient was repeated once, which resulted (b)(6).The corrected (b)(6) results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant (b)(6) results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse evaluated the instrument and instrument data.The cse replaced the incubation ring belt and checked the sample probe, (b)(6) probe and wash probe alignments.The cse also performed an acid and base volume check.The cause of the discordant (b)(6) results is unknown.The cse successfully ran quality controls and samples.The instrument is performing 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 avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; registration number: 8020888; chapel lane, swords; co. dublin, ; EI
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 4561333
• MDR Text Key: 5471147
• Report Number: 2432235-2015-00102
• Device Sequence Number: 1
• Product Code: OBF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2007
• 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