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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 06/12/2014

Event Type  malfunction  

Event Description

Falsely high advia centaur xp folate red blood cell (rbc) results were observed by the customer on a patient sample.The initial test result on the rbc hemolysate sample was over-range and the auto dilution result was high, however, on repeat the test results were within range limits.The customer ran the patient sample on another advia centaur system and observed similar folate red blood cell (rbc) results.A new rbc hemolysate sample was prepared due to the false high test results and run on both advia centaur systems.The new hemolysate sample test results were lower.There are no known reports of patient treatment being altered or prescribed or adverse health consequences due to the high advia centaur xp folate results.

Manufacturer Narrative

The cause for the initially false high (> 24) advia centaur xp folate red blood cell (rbc) results observed by the customer on the patient's rbc hemolysate test sample is unknown.Preventative maintenance was completed on both advia centaur systems and the customer's system maintenance was acceptable.The customer performed an rbc hemolysate auto dilution when the initial result was over-range, however this is considered a use error.No conclusion can be drawn.The instruction for use (ifu) states the following under the procedural notes for dilution and preparing the red blood cell hemolysate: "do not dilute the rbc hemolysate." the advia centaur systems are performing within specifications.

• Brand Name: ADVIA CENTAUR XP FOLATE (FOL) ASSAY
• Type of Device: FOLATE IMMUNOASSAY, PRODUCT CODE:
• 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: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 3943731
• MDR Text Key: 4598524
• Report Number: 1219913-2014-00185
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K010050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 10/06/2014
• Device Model Number: N/A
• Device Catalogue Number: 06891541
• Device Lot Number: 071227
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• 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
• Patient Sequence Number: 1