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

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 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant afp results is unknown.The type of blood collection tube used is gel bd (beckton dickinson).The sample allowed to clot for one hour at ambient temperature.The sample was centrifuged before it was initially tested for 10 minutes at 1600 rcf (relative centrifugal force) at 20 degrees celsius.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 false high advia centaur xp afp result was obtained for a patient sample.The result was reported to the physician and questioned as the previous result was negative.A new patient sample was received and tested.The result was negative.The initial patient sample was repeated and the result was negative.A corrected report was issued.The patient's pre-existing medical condition is hemochromatosis.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant afp results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2018-00001 on 11-jan-2018.12-feb-2018 additional information: the cause for the discordant afp results is unknown.Siemens performed an assessment of the internal advia centaur xp afp lot 186 data and did not identify any non-repeatable elevated results (flyers).Therefore, the lot 186 is performing as intended.No issues were identified with the customer's sample handling procedures.The instrument is performing within specifications.No further evaluation of the device is required.

• 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
• MDR Report Key: 7183712
• MDR Text Key: 97746644
• Report Number: 1219913-2018-00001
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (y/n): N
• PMA/PMN Number: P930036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 186
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR