MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; CLINICAL CHEMISTRY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problem Mechanical Problem (1384)

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

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer stated they reviewed the sample and did not find any issues with it.A review of the customer's calibration and quality control (qc), shows it was in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse found a base pump leak.The cse installed a new pump and verified proper operation.The cse performed calibration and qc, resulting within range.The customer ran patient samples for verification, resulting within the expected ranges.A siemens headquarters support center (hsc) reviewed the event.Hsc stated this is an inverse assay.With inverse assays, a higher relative light unit (rlu) result would produce a low patient result.A leaking base pump usually indicates that less base was dispensed, causing a lower rlu and a higher result.The cse did not find any system contamination or errors associated with this issue.The issue could not be confirmed.The cause of the discordant, falsely depressed br 27.29 results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely depressed br 27.29 (cancer antigen 27.29) results were obtained on two patient samples on an advia centaur xp instrument.The initial results were reported out to the physician(s), which was questioned.The customer repeated the same samples on the same advia centaur xp instrument, resulting higher.Corrected reports were issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed br 27.29 results.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; registration number: 8020888; chapel lane; swords, co, dublin ; EI
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6455399
• MDR Text Key: 71588519
• Report Number: 2432235-2017-00234
• 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: 04/03/2017

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 XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2007
• 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