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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and the quality controls (qc) were valid when the samples were run.The tube/sample type was serum tubes bd vacutainer cat 6 ml.The samples were centrifuged at 4000 rpm for 15 minutes.A siemens field service engineer (fse) was sent to the customer site for system inspection.The fse noticed an anomaly in the dispensation test of reagent probe 3.The fse replaced the probe and performed the calibration of reagent probes position.The fse also checked the wash1 line, performed calibration, and ran quality controls.The customer monitored for several days post service with no additional events.The initial low result and repeat results were from the same reagent readypack.The calibration and qc were valid.No other patient samples were affected.Sample handling is routine for the tube type.The cause of the initial low ca 15-3 result cannot be determined.However, we cannot rule out an instrument/probe issue that was corrected by service.The instrument is performing within specifications.No further evaluation of the device is required.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.".
Event or Problem Description
A discordant low advia centaur xpt ca 15-3 result was obtained on a patient sample.The patient sample was repeated, and the result was high.Another sample from the same patient was tested and the result was high.The initial low result was not reported to the physician.The final result reported to the physician was the result of 147 u/ml.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
• Common Device Name: CA 15-3 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9137855
• Report Number: 1219913-2019-00170
• Device Sequence Number: 13909650
• Product Code: MOI
• UDI-Device Identifier: 00630414461311
• UDI-Public: 00630414461311
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K012357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

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: Health Professional
• Device Expiration Date: 02/06/2020
• Device Model Number: N/A
• Device Catalogue Number: 10327620
• Device Lot Number: 40601177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR