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

Model Number ADVIA CENTAUR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.The cse inspected the wash and aspiration operations at the wash manifold.The cse checked the acid and base volume, inspected calibrations of the sample probe, ancillary probe and reagent probes and checked the dispense heights.The cse ran dark counts with cuvettes and performed precision testing.The customer repeated other patient samples and verified that they were all acceptable.The customer stated that the discordant result was an isolated event.The cause of the discordant, falsely low ca 27.29 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 low cancer antigen 27.29 (ca 27.29) result was obtained on one patient sample on an advia centaur instrument.The discordant result was reported to the physician(s), who questioned it.The sample was repeated on the same instrument, resulting higher and matching the clinical picture of the patient.The corrected result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low ca 27.29 result.

• Brand Name: ADVIA CENTAUR
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): CHIRON DIAGNOSTICS CORPORATION; 132 artino street; oberlin OH 44074 1293
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5702892
• MDR Text Key: 46690154
• Report Number: 2432235-2016-00298
• Device Sequence Number: 0
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: No
• 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