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 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse replaced the acid and base pump and sample syringe, cleaned the wash station and luminometer, checked the acid, base, reagent, and sample dispenses, and calibrated the sample and reagent probes.A siemens regional support center specialist reviewed the instrument data, which was indicative that either there was no sample in the cuvette or there was no acid/base solution to create a reaction.The cause of the discordant psa result on one patient sample is unknown.Siemens is investigating the issue.

Event Description

A discordant prostate specific antigen (psa) result was obtained on one patient sample on an advia centaur cp instrument.The customer stated that the initial result was normal.The sample was repeated on the same instrument as the patient had a history of prostate disease.The sample was repeated on an unknown instrument and a different value was obtained.It is unknown which result was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant psa result.

Manufacturer Narrative

The initial mdr 2432235-2018-00132 was filed on (b)(6) 2018.Additional information (23-mar-2018): a siemens customer service engineer (cse) re-visited the customer site.After analyzing the instrument, the cse checked the alignments and sample and reagent dispense.The cse replaced the reagent syringe and dilutor and checked the reagent probe, tip adapter and performance of wash blocks.The cse replaced the wash station, grey peri-pump waste tubings, snap platens on top of the peri-pumps, and dispense acid port.A siemens headquarters support center (hsc) specialist reviewed the service report and determined that several of the parts replaced and actions taken could have been the cause of the discordant result.The instrument is performing within manufacturing specifications.No further evaluation of device is required.Additionally, the reporting unit for prostate specific antigen is ng/ml.Section has been updated with this information.Mdr 2432235-2018-00162 has been filed for the same issue.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7379720
• MDR Text Key: 103950686
• Report Number: 2432235-2018-00132
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1