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

Model Number ADVIA CENTAUR

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

Discordant cancer antigen 27.29 (ca 27.29) results were obtained on two patient samples on an advia centaur instrument.The initial results were reported to the physician(s).The laboratory manager questioned the results and quality controls were run, resulting out of range.The customer recalibrated the assay, reran quality controls and repeated the samples on the same instrument, and the corrected results were obtained.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant ca 27.29 results.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer reported that on january 8th, 2015, quality controls (qc) were out of range.The customer dispatched their own internal service to check the instrument.It is unknown what actions were taken by the service personnel.The following day, discordant results were obtained on the instrument, after which the customer ran quality controls, which were out of range.The customer recalibrated the assay and reran qc, after which the correct results were obtained.On a later date, a siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse discovered a failed 3 way solenoid cleaning valve and bleach in the system.The cse replaced valves 66 and 67, and cleaned the dispense ports on the wash station.Qc were run, resulting within range.The cause of the discordant ca 27.29 results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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 10591 ; 9145242687
• MDR Report Key: 4516262
• MDR Text Key: 18034916
• Report Number: 2432235-2015-00067
• Device Sequence Number: 1
• Product Code: MOI
• 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 Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR
• Device Catalogue Number: 078-A001-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2007
• 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