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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens field service engineer (fse) verified the instrument performance was acceptable.The technical application specialist (tas) tested the sample and the results were high.The sample was frozen and thawed between the initial test and the repeat test.It was not centrifuged after thawing.When the sample was again repeated, it recovered at 465 u/ml and 510 u/ml.The patient was redrawn and the new sample recovered 496 u/ml and 522 u/ml.The cause for the discordant ca 125ii result is unknown.Possible sample handling issue.The instrument is performing within specifications.No further evaluation of the device is required.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 or Problem Description
A discordant low advia centaur xp ca 125ii result was obtained on a patient sample upon repeat at a later date.The patient sample was repeated after the customer changed the range from 0-320 to 2-600u/ml.The sample was tested initially and the value was >320.The patient sample was diluted and the result was higher.This result was reported to the physician and was not questioned.The sample was repeated again after thawing.The results were higher.A redraw sample was tested by the technical application specialist (tas) and the results were high.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca125ii result,.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00158 on july 25, 2017.07/25/2017 correction: the name of the paltform was listed incorrectly in the initial mdr.The instrument that was used for testing by the customer was the advia centaur cp and not the advia centaur xp.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP CA 125II ASSAY
• Common Device Name: CA 125II IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 6739731
• Report Number: 1219913-2017-00158
• Device Sequence Number: 19144041
• Product Code: LTK
• UDI-Device Identifier: 00630414461298
• UDI-Public: 00630414461298
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2017

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
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 12/19/2017
• Device Model Number: N/A
• Device Catalogue Number: 10310443
• Device Lot Number: 173
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/01/2017
• Patient Sequence Number: 1