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

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 02/09/2015

Event Type  malfunction  

Event Description

The customer ran quality control (qc) level 2 in the afternoon (pm) and observed a low recovery result on the advia centaur xp ca 125ii assay.The qc level 3 was run and a low recovery result was also observed.The qc level 1 and qc level 3 had only been run in the morning (am) and were within acceptable ranges.The ca 125ii reagent readypack was replaced with a new readypack of the same reagent lot and the qc results were within acceptable ranges.The customer repeated the patient samples that were run prior to the observed qc level 2 low recovery issue and the results with the new reagent readypack were higher.Amended results were reported to the physician(s).There was no report of patient treatment being prescribed or altered and there was no report of adverse health consequences due to the discordant advia centaur xp ca 125ii results.

Manufacturer Narrative

The cause for the advia centaur xp ca 125ii observed low qc level 2 recovery and patient results may have been attributed to specific reagent readypack related issue.The new reagent readypack was from the same reagent lot and from the same original reagent shipment to the customer.Siemens checked advia centaur readypacks reagent lot 015163 retains and observed normal recovery.The original readypack had been in use by the customer for a few hours, therefore an onboard reagent stability issue is unlikely.The original reagent readypack will not be returned to siemens for further investigation.No conclusion can be drawn.The instructions for use (ifu) states the following under the limitations section: "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.No further evaluation of the device 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: 4566053
• MDR Text Key: 5547275
• Report Number: 1219913-2015-00057
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/09/2015

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: 07/21/2015
• Device Model Number: N/A
• Device Catalogue Number: 09427226
• Device Lot Number: 015163
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/03/2015
• 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