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

Model Number ADVIA CENTAUR XP

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

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

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer called regarding calibration issues with the method, which were resolved by recalibration.The customer then informed ccc of obtaining a discordant result.The customer calibrated a fresh reagent pack with a fresh calibrator.Quality controls were within range.The sample was then repeated, resulting lower.A customer service engineer (cse) was dispatched to the customer's site.The cse inspected the system and found no issues or problems.In a follow-up by the ccc it was discovered that the customer is calibrating every three (3) days and has the reagent set to do not use beyond.The customer is a high volume, using one reagent pack every 2-3 days.The customer is not calibrating each new reagent pack.Review of the events log, indicate no instrument issue.The customer stated that they have opened an internal complaint for improper reagent handling issue, and have put in place 7 day calibration and to calibrate all new reagent packs.As per advia centaur, advia centaur xp, and advia centaur xpt systems cancer antigen 27.29 instructions for use, the user is to perform calibration every 7 days and requires a two-point calibration when changing lot numbers of primary reagent packs, replacing system components and when quality control (qc) results are repeatedly out of range.Technical applications specialist (tas) worked with the customer to resolve reagent handling issues by changing calibration to every 7 days and when a new pack is loaded.The cause of the discordant, cancer antigen 27.29 results is due to a reagent handling issue by the user.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant cancer antigen 27.29 (ca 27.29) result was obtained on one patient samples (patient 1) on an advia centaur xp instrument.The initial result was reported to the physician(s), who questioned it.The sample was repeated on the same advia centaur xp instrument, after recalibration, resulting lower.The customer pulled all patient samples reported on (b)(6) 2016 for ca 27.29 to repeat testing.The samples were repeated at an alternate laboratory.The customer reported they had filed multiple amended reports.There are no known reports of patient intervention or adverse health consequences due to the discordant, cancer antigen 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 LIMIT; registration number: 8020888; chapel lane; swords, co, dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5707642
• MDR Text Key: 46863214
• Report Number: 2432235-2016-00306
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• 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
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2012
• 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