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

Model Number ADVIA CENTAUR CP

Device Problem Mechanical Problem (1384)

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

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse took out the luminometer and cleaned it.The cse ran dark counts several times and obtained interference.The cse cleaned the ionizer fan and cuvette bin and reran dark counts, which were acceptable.During the follow-up visits, the cse replaced the luminometer and ionizer and then performed the assay calibration, which failed.The cse replaced the wash block assembly, verified that there were no leaks and the acid and base dispenses were functioning properly.The cse performed daily cleaning and ran calibrations and quality controls, which were acceptable.The cause of the discordant ca 27.29 results on two patient samples 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 (b)(6) 2016 on an advia centaur cp instrument.The discordant result was reported to the physician(s), who questioned it.The sample was repeated on the same instrument and resulted higher and as expected based on the patient's history.The corrected result was reported to the physician(s).The operator then performed a look-back on other patient samples and discovered one additional discordant ca 27.29 result from (b)(6) 2016.The discordant result was falsely high and had been reported to the physician(s).The sample was repeated on the same instrument and resulted lower and aligned with the patient's history.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant ca 27.29 results.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; gewerbestrasse 6; neuhausen am rheinfall, 8212 ; SZ 8212
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5806019
• MDR Text Key: 49914896
• Report Number: 2432235-2016-00384
• 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: 07/19/2016

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 CP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/19/2016
• 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