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

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2013

Event Type  malfunction  

Event Description

Customer observed an increase in the patient running mean for advia centaur xp folate when using reagent lot 071223 when compared to previous reagent lots.There are no known reports of patient treatment being altered or prescribed or adverse health consequences due to the increased advia centaur xp folate results.

Manufacturer Narrative

The cause for the observed increase in the patient running mean for advia centaur xp folate when using reagent lot 071223 when compared to previous reagent lots is unknown and is currently under investigation.Additional representative data has been requested by siemens.No conclusions can be drawn at this time.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2014-00006 on january 9, 2014 for an increase in patient running mean for advia centaur xp folate whole blood cell samples when using reagent lot 071223 when compared to previously used reagent lots.April 9, 2014 - additional information customer patient running mean per reagent lot.Results do not include the whole blood cell calculation.Reagent lot number: 071211, ng/ml: 8.33 , nmol/l: 18.87; 071212, 8.84, 20.02; 071213, 7.5, 16.99; 071214, 7.49, 16.96; 071215, 8.9, 20.16; 071216, 9.06, 20.52; 071217, 8.38, 18.98; 071218, 7.4, 16.76; 071219, 9.28, 21.02; 071222, 12.54, 28.40; 071223, 12.69, 28.74; 071225, 12.26 , 27.77.Based upon additional information and investigation, on march 25, 2014, siemens issued an urgent medical device recall (108180053) to its customers in the united states and an urgent field safety notice (10818055) to its customers outside of the united states, related to the advia centaur folate assay.Siemens has determined that the advia centaur systems folate assay, kit lots ending in 222, 224, 225, 226 and/or 227, meets the published claims in the ifu for normal whole blood cell folate.The whole blood cell folate results for lots ending in 219 may show a negative bias of up to (b)(4) relative to new lots 224, 225, 226, and 227.This negative bias may result in a patient receiving folate supplementation; however, this supplementation does not constitute a risk to health.

• Brand Name: ADVIA CENTAUR XP FOLATE (FOL) ASSAY
• Type of Device: FOLATE IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 3566494
• MDR Text Key: 4047544
• Report Number: 1219913-2014-00006
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K010050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/12/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2014
• Device Model Number: N/A
• Device Catalogue Number: 06891541
• Device Lot Number: 071223
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1219913-03/25/2014-001-R
• Patient Sequence Number: 1