MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 125II ASSAY; CA 125II IMMUNOASSAY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Breast Cancer (1759)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

The cause for the false low advia centaur xp ca 125ii patient result when run undiluted is unknown.The customer's quality control results were acceptable at the time of the incident.Siemens is investigating.The instructions for use (ifu) states the following under the limitations section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." "note: do not interpret levels of ca 125 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed ovarian carcinoma frequently have levels of ca 125 within the range observed in healthy individuals.Elevated levels of ca 125 can be observed in patients with nonmalignant diseases.Measurements of ca 125 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.The concentration of ca 125 in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Ca 125 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity." the instrument is performing with specifications.

Event Description

A false low advia centaur xp ca 125ii result was obtained on a patient sample and questioned by the physician.The low result was considered discordant compared to an elevated ca 125 result from an alternate laboratory and test method.The patient sample was diluted, repeat testing performed on the advia centaur xp ca125ii test method, and results were higher.There was no known report of patient treatment being altered or prescribed or adverse health consequences due to the discordant advia centaur xp ca 125ii result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2015-00184 on 11/20/2015 for false low advia centaur xp ca 125ii patient result when run undiluted.On 12/09/2016 - additional information: siemens performed internal hook sample testing with a ca 125ii hook concentration > 70,000 u/ml.The hook concentration recovered >600 u/ml when run with the advia centaur ca 125ii assay, indicating the issue is sample specific.The advia centaur xp ca 125ii assay is performing as intended.The instruction for use (ifu) under the high-dose hook effect section states the following: "patient samples with high ca 125 levels can cause a paradoxical decrease in the rlus (high-dose hook effect).In this assay, ca 125 levels as high as 70,000 u/ml will assay greater than 600 u/ml." the instructions for use (ifu) states the following under the limitations section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." "note: do not interpret levels of ca 125 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed ovarian carcinoma frequently have levels of ca 125 within the range observed in healthy individuals.Elevated levels of ca 125 can be observed in patients with nonmalignant diseases.Measurements of ca 125 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.The concentration of ca 125 in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Ca 125 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity." the instrument is performing within specifications.No further investigation is required.

• Brand Name: ADVIA CENTAUR XP CA 125II ASSAY
• Type of Device: CA 125II 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: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 5239006
• MDR Text Key: 31702197
• Report Number: 1219913-2015-00184
• Device Sequence Number: 1
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2015
• Device Model Number: N/A
• Device Catalogue Number: 09427226
• Device Lot Number: 015165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2014
• 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: 53 YR