MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT CA 15-3; 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	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant advia centaur xpt ca 15-3 result.Siemens is investigating.The instruction for use (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 high advia centaur xpt ca 15-3 result was obtained on patient sample.The customer performed repeat testing on an atellica im system, resulting lower.The lower ca 15-3 repeat result was reported to the physician(s) as the corrected result.There are no known reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xpt ca 15-3 result.
Additional Manufacturer Narrative
Mdr (b)(4) was filed on (b)(6)2020 for discordant high advia centaur xpt ca 15-3 patient result.(b)(6)2020 - additional information: siemens was informed that the customer did not notify the fda of the incident.E4 was updated from "unknown" to "no".Siemens was provided the customer contact person: christos dinas (laboratory manager) the sample type was serum.The atellica ca 15-3 reagent lot was 178.Siemens has reviewed the information provided and has concluded the incident investigation.The advia centaur xpt higher result may be correct.The customer ran the same patient sample on both the advia centaur xpt and atellica im systems the same day.Quality control (qc) were in range on both systems and sample integrity was observed to be acceptable.The advia centaur xpt ca 15-3 result 33.2 u/ml (positive) was slightly above the assay cutoff (32.4 u/ml) and atellica im result (24.4 u/ml) was below the assay cutoff (32.4 u/ml).Around the time of the incident, atellica im instrument issues were observed that led to technical intervention including alignments and probe change.Particle residue was also observed in the ca15-3 reagent readypack in use.Based on the information provided, the potential cause of the lower atellica im ca 15-3 result compared to the higher advia centaur xpt ca 15-3 is unknown.However, instrument maintenance issues and/or reagent pack integrity cannot be ruled out as potential causes.The customer is operational.The assay is performing within specification.No further evaluation of the device is required.Section h6 result and conclusion codes were updated to reflect the additional information.

• Brand Name: ADVIA CENTAUR XPT CA 15-3
• Common Device Name: CA 15-3 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9908170
• Report Number: 1219913-2020-00095
• Device Sequence Number: 13616865
• Product Code: MOI
• UDI-Device Identifier: 00630414461311
• UDI-Public: 00630414461311
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Followup
• Report Date (Section B): 05/19/2020

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: 04/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 10327620
• Device Lot Number: 20789179
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1