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 03/26/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant (b)(6) total results is unknown.The patient sample is not available for further testing and investigation.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

(b)(6) result was obtained for a patient sample.The physician questioned the results.The patient sample was tested on an alternate method and the result was (b)(6).The (b)(6) result matched the clinical context of the patient.Patient treatment was not 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: 5643637
• MDR Text Key: 44894156
• Report Number: 1219913-2016-00074
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2016
• Device Model Number: N/A
• Device Catalogue Number: 10322676
• Device Lot Number: 104178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2015
• 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
• Patient Age: 30 YR