MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP BR (27.29 ) ASSAY; IMMUNOLOGICAL TEST FOR BR (27.29) ANTIGEN

Model Number N/A

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

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

Event Date 12/26/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer's site for system inspection.The cse performed a total service check and calibrated the ancillary probe at the cuvette, replaced the photo multiplier tube (pmt) due to cps signal errors, luminometer cover and worn o-ring, and checked dark counts.The dry, water, and wash 1 system checks were acceptable.The br (ca27.29) assay was recalibrated, ten quality control (qc) replicates were run and the results were within qc range.Four patient samples previously observed for signal errors were repeated without errors.The cause for the discordant advai centaur xp br (ca 27.29) is unknown.Siemens is investigating.The limitations section under the warning/note section of the instructions for use (ifu) states the following: "do not interpret levels of ca 27.29 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 27.29 within the range observed in healthy individuals.Additionally, elevated levels of ca 27.29 can be observed in patients with nonmalignant diseases.Measurements of ca 27.29 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".

Event Description

An elevated advia centaur xp br (assay for ca 27.29) result was obtained by the customer on a patient sample (secondary tube).The result was questioned by the client due to a lower br test result from (b)(6).The same sample (secondary tube) was re-run neat, and the result was lower.The sample was run a third time, and the br results were elevated.The patient sample (same secondary tube), and another sample tube was pulled, re-run on an alternate advia centaur system (irl97140932), and the results were elevated.The original br result from (b)(6) was questioned by the physician.There are no known reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp br (assay for ca 27.29) result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00277 on (b)(6) 2017 for an elevated advia centaur xp br (assay for ca 27.29) result on a patient sample.On 01/20/2017 - additional information: the patient result of 852 u/ml (auto-dilute 1:10) drawn on (b)(6) 2016, and the patient result of 1174 u/ml from (b)(6) 2016 were considered the correct results.On 02/01/2017 - additional information: based on the actions taken by the siemens customer service engineer (cse), and primarily the replacement of the pmt, there has been no further discordant patient results observed by the customer.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00277 on 01/23/2017 for an elevated advia centaur xp br (assay for ca 27.29) result on a patient sample, and mdr 1219913-2016-00277 supplemental report 1 on 02/17/2017 for additional information.On 02/21/2017: correction - the repeat results ((b)(6) 2016) from another sample tube was for (b)(6) and not (b)(6) as originally reported.Please note that both sids are from the same patient.The instrument sn did not change, only the sid.Instrument sn: (b)(4), (b)(6).Repeat results from another sample tube: (b)(6) 2016 >450 (neat), 852 (auto-dilute 1:10).On 02/21/2017: additional information - the customer has provided the results of four other patients not originally provided.(b)(6).Based on the actions taken by the siemens customer service engineer (cse), and primarily the replacement of the pmt, there has been no further discordant patient results observed by the customer.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP BR (27.29 ) ASSAY
• Type of Device: IMMUNOLOGICAL TEST FOR BR (27.29) ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; e. walpole, MA 02032 ; 5086604163
• MDR Report Key: 6271665
• MDR Text Key: 65631582
• Report Number: 1219913-2016-00277
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 02/10/2017
• Device Model Number: N/A
• Device Catalogue Number: 10333349
• Device Lot Number: 53919219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1