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

Model Number ADVIA CENTAUR XP

Device Problem Mechanical Problem (1384)

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

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluating the instrument, the cse performed a total service call.The cse discovered intermittent and inconsistent dispense of acid from the acid pump assembly.The acid pump assembly was replaced and pump calibrations were verified.The cse performed the dry wet water, wet wash 1 tests.The cse calibrated the method and ran all quality controls, resulting within range.A siemens headquarter support center (hsc) specialist evaluated the event data.Hsc concluded that accurate addition of 300 ul of acid fluid into the cuvette during sampling is critical in the measurement of patient results.If acid was dispensing inconsistently it could have been a contributing factor in the erratic results that were observed.The cause of the discordant ca 27.29 results on two patient samples was a malfunction of the acid pump assembly.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely low cancer antigen 27.29 (ca 27.29) results were obtained on one replicate when tested in duplicate on two patient samples on an advia centaur xp instrument.The low results obtained on the first replicates were reported to the physician(s).The results of the second replicates were reported as corrected.There are no known reports of patient adverse health consequences due to the discordant ca 27.29 results.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; chapel lane; swords, co., dublin el, ; SZ
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5477873
• MDR Text Key: 39644281
• Report Number: 2432235-2016-00111
• 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: 02/05/2016

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 XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2008
• 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