MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP ASSAY AFP IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

The repeat testing was performed using the same sample, without additional centrifugation between initial and repeated measurements. The sample tube was a serum tube with gel separator from greiner bioone. The sample was centrifuged for 10 minutes at 2000xg after a clotting time of 30 minutes. The quality control and adjustment were valid. The performance of other tests was good, so system malfunction is unlikely. The cause for the discordant afp results is unknown. Siemens healthcare diagnostics is investigating. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings".

Event Description

A discordant high advia centaur xp afp result was obtained for a patient sample. The patient sample was repeated and the results were lower. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant afp results.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Type of Device: AFP IMMUNOASSAY
• 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: 8171216
• MDR Text Key: 131792563
• Report Number: 1219913-2018-00302
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K020806
• 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
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/15/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 09370199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial