MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP VB12 ASSAY; VB12 IMMUNOASSAY

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

Discordant advia centaur xp vb12 (vitamin b12) results were obtained on samples from eleven patients.The customer observed a drift in patient results after the post run of internal quality control.The vb12 reagent pack and the ancillary reagent pack were replaced.Repeat testing was performed on the patient samples.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the vb12 discordant results.

Manufacturer Narrative

The cause for the discordant vb12 results is unknown.The vb12 reagent pack and the ancillary reagent pack were replaced.Possible bad reagent pack or ancillary reagent pack.The instrument is performing within specification.The ifu states in the quality control section: "if the quality control results do not fall within the expected values or within the laboratory's established values, do not report results.Take the following actions: -verify that the materials are not expired.-verify that required maintenance was performed.-verify that the assay was performed according to the instructions for use.-rerun the assay with fresh quality control samples.-if necessary, contact your local technical support provider or distributor for assistance." the ifu states in the limitations section: "preservatives, such as fluoride and ascorbic acid interfere with the advia centaur vb12 assay.Excessive exposure to light may alter vitamin b12 values.Dispose of the dtt/releasing agent ancillary reagent pack after 108 hours.".

Manufacturer Narrative

On 03/31/2014 additional information: subsequent reagent packs were performing as expected and the issue was related to the one reagent pack.Replacing the reagent pack resolved the issue.The units used by the customer were pg/ml for reporting results.The customer requires no further assistance at this time.

• Brand Name: ADVIA CENTAUR XP VB12 ASSAY
• Type of Device: VB12 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• 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: 3628329
• MDR Text Key: 4206384
• Report Number: 1219913-2014-00048
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K993571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: N/A
• Device Catalogue Number: 09544818
• Device Lot Number: 215
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 02/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2014
• 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