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 11/13/2015

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 cause for the discordant (b)(6) total results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the taking corrective action section: "if the quality control results do not fall within the expected values or within the laboratory's established values, do not report results.Take the following actions: verify that the materials are not expired.Verify that required maintenance was performed.Verify that the assay was performed according to the instructions for use.Rerun the assay with fresh quality control samples.-if necessary, contact your local technical support provider or distributor for assistance." the ifu states in the interpretation of results section: "sample results are invalid and must be repeated if the controls are out of range." the ifu states in the limitations section: "the results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.A nonreactive test result does not exclude the possibility of exposure to hepatitis a virus.".

Event Description

Discordant advia centaur xp hav total (ahavt) results were obtained for samples from several patients.The initial (b)(6) total results were (b)(6) when repeated.The patient samples were repeated when the (b)(6) total quality control (qc) was out of range high.The assay was recalibrated and the qc repeated.The qc was in range.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.

• 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: 5263639
• MDR Text Key: 32596972
• Report Number: 1219913-2015-00186
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2016
• Device Model Number: N/A
• Device Catalogue Number: 10309522
• Device Lot Number: 104068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2015
• 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