MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HAV TOTAL (AHAVT); TOTAL ANTIBODY TO HEPATITIS A VIRUS

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 10/18/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer (fse) was sent to the customer site.The fse performed a total service call.No issues were identified.The technical application specialist (tas) reviewed the calibration and quality control.No issues were identified.The cause for the discordant hav total results is unknown.Siemens healthcare diagnostics is investigating.The instrument is performing within specifications.

Event Description

Discordant advia centaur xp (b)(6) total (ahavt) results were obtained for samples from several patients.One result was reactive and the other result was nonreactive.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the discordant (b)(6) total results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00016 on february 02, 2016.On 02/08/2016 additional information: before testing the patient samples at a different location on (b)(6), a siemens field service engineer (fse) was sent to the customer site.In this visit, the fse had done the following replacements: cleaning solution valves, kit base pump, kit acid pump, and sample pipettor dispenser (sample syringe).After these parts were replaced, the hav total assay was calibrated and quality control (qc) was performed and passed.The instrument was monitored.The technical application specialist (tas) had recently gone on site and reviewed the data generated since the service call.The percentage of samples with results between 0.8 and 2.0 was reduced to 1.7% form 25% (n=276).Any of the parts replaced by the fse could have been the cause of this problem.Therefore, the specific part that caused the issue could not be determined.The cause for the discordant hav total results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP HAV TOTAL (AHAVT)
• Type of Device: TOTAL ANTIBODY TO HEPATITIS A VIRUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 5404255
• MDR Text Key: 37339996
• Report Number: 1219913-2016-00016
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2016
• Device Model Number: N/A
• Device Catalogue Number: 10322676
• Device Lot Number: 104066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2015
• 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