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 No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ca 125ii result is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the dilutions section: "serum samples with ca 125 levels greater than 600 u/ml must be diluted and retested to obtain accurate results." the ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in 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 concentration of ca 125 in a given specimen determined with assays from different manufacturers can vary because of 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.Therefore, it is important to use assay specific values to evaluate quality control results.".

Event Description

A discordant low advia centaur xp ca 125ii result was obtained on a patient sample.The patient sample was tested on an alternate method and an interferent error was obtained.The patient sample was diluted and tested on the alternate method.The result was high.The diluted sample was then retested on the advia centaur xp ca 125ii and the result was high.The patient was tested previously in (b)(6) and the diluted result was high.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca 125ii result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00260 on january 6, 2017.On 03/22/2017 correction: the kit lot number of the initial mdr was incorrect.The correct kit lot # is 03808170 and the expiration date is 3/31/2017.(b)(4).On 3/22/2017 additional information: the customer sent two samples for further testing and investigation.The samples were tested with advia centaur xp ca 125ii reagent lot 051172.Results: sample (b)(6): neat replicate 1: >600, neat replicate 2: >600, dilution 1:100 replicate 1: 51,510, dilution 1:100 replicate 2: 52,920, dilution 1:100 replicate 3: 48,830.Sample (b)(6): neat replicate 1: >600, neat replicate 2: >600, dilution 1:100 replicate 1: >600, dilution 1:100 replicate 2: >600, dilution 1:100 replicate 3: >600.Siemens was not able to to confirm the customer observation of values <600 u/ml with advia centaur xp ca 125ii reagent lot 051170.The testing was performed with reagent lot 05172 and results obtained were > 600 u/ml neat and > 50,000 u/ml when diluted 1:100.The cause for the discordant advia centaur xp ca 125ii result is unknown.There may have been a shipping/handling issue with the customer's reagents.The instrument is performing within 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.; 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: 6229173
• MDR Text Key: 64064158
• Report Number: 1219913-2016-00260
• Device Sequence Number: 1
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: N/A
• Device Catalogue Number: 10315696
• Device Lot Number: 42045171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2016
• 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: 61 YR