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

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2014

Event Type  malfunction  

Event Description

High advia centaur xp cea results were obtained on samples from the same patient.The patient samples were tested on two different alternate methods and the results were low.Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant advia centaur xp cea result.

Manufacturer Narrative

The cause for the discordant advia centaur xp cea result is unknown.The instrument is performing within specifications.No further evaluation fo the device is required.The instruction for use (ifu) limitation section states: "note: do not interpret levels of cea as absolute evidence of the presence or the absence of malignant disease.Measurements of cea should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.The concentration of cea in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Cea determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Warning: do not use the advia centaur cea immunoassay as a screening test for diagnosis.Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.".

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2014-00121 on may 9, 2014.05/13/2014 correction: (b)(6).

• Brand Name: ADVIA CENTAUR XP CEA ASSAY
• Type of Device: CEA 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: 3802270
• MDR Text Key: 20787911
• Report Number: 1219913-2014-00121
• Device Sequence Number: 1
• Product Code: DHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K981478
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2014
• Device Model Number: N/A
• Device Catalogue Number: 00937450
• Device Lot Number: 040154
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2014
• 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
• Patient Age: 50 YR