MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP FOLATE (FOL) ASSAY; FOLATE IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the falsely elevated advia centaur xp folate (fol) result is being investigated by siemens.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
A falsely elevated advia centaur xp folate (fol) result was obtained on a patient sample and considered discordant when compared to lower dilution results, and a normal vitamin b12.The falsely elevated folate result was not reported to the provider.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated centaur xp folate result.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2018-00109 on 03/06/2018 for a falsely elevated advia centaur xp folate (fol) result.04/23/2018 - additional information: the patient sample was tested by siemens for biotin interference.The biotin level in the serum sample was negligible, indicating no evidence of biotin interference.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the elevated neat value, pre-analytical factors or sample issue cannot be ruled out.Sid biotin level (b)(6).1.33 ng/ml.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP FOLATE (FOL) ASSAY
• Common Device Name: FOLATE IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7317605
• Report Number: 1219913-2018-00109
• Device Sequence Number: 110418
• Product Code: CGN
• UDI-Device Identifier: 00630414204192
• UDI-Public: 00630414204192
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2018
• Device Model Number: N/A
• Device Catalogue Number: 10310308
• Device Lot Number: 071258
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR