MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT CA 15-3 ASSAY; CA 15-3 IMMUNOASSAY

Model Number N/A

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

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

The customer suspected the reagent readypack due to extremely low quality control and patient results.The customer stores some of their readypacks in closed boxes when in the refrigerator.The refrigerator where the readypacks are stored has glass doors and sometimes the internal light below the readypacks was left on.The customer cannot say whether the boxes are close to the light.Siemens healthcare diagnostics recommended to the customer to store ca15-3 reagent kits as far away from the light as possible.The cause for the discordant advia centaur xpt ca15-3 results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the storing and stability section: "store the reagents upright at 2-8°c.Protect reagent packs from all heat and light sources.Reagent packs loaded on the system are protected from light.Store unused reagent packs at 2-8°c away from heat and light sources.All reagents are stable at 2-8°c until the expiration date on the packaging." the ifu states in the limitation section: "note: do not interpret levels of ca 15-3 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 15-3 within the range observed in healthy individuals.Additionally, elevated levels of ca 15-3 can be observed in patients with nonmalignant diseases.Measurements of ca 15-3 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." note: product availability may vary from country to country and is subject to varying regulatory requirements.Due to local regulations, the advia centaur xpt is not available in all countries.

Event Description

Discordant advia centaur xpt ca 15-3 results were obtained for samples from two patients.The initial results were low.The customer suspected the reagent readypack was defective.The patient samples were repeated on another instrument with a different reagent readypack.The repeat results were high.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca 15-3 results.

• Brand Name: ADVIA CENTAUR XPT CA 15-3 ASSAY
• Type of Device: CA 15-3 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• 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: 5512152
• MDR Text Key: 40728058
• Report Number: 1219913-2016-00056
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K012357
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2016
• Device Model Number: N/A
• Device Catalogue Number: 10327620
• Device Lot Number: 043159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2015
• 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