MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP ASSAY; AFP 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	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The repeat testing was performed using the same sample, without additional centrifugation between initial and repeated measurements.The sample tube was a serum tube with gel separator from greiner bioone.The sample was centrifuged for 10 minutes at 2000xg after a clotting time of 30 minutes.The quality control and adjustment were valid.The performance of other tests was good, so system malfunction is unlikely.The cause for the discordant afp results is unknown.Siemens healthcare diagnostics is investigating.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 high advia centaur xp afp result was obtained for a patient sample.The patient sample was repeated and the results were lower.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant afp results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00302 on 17-dec-2018.07-jan-2019 additional information: a siemens field service engineer (fse) was sent to the customer site.The fse changed the base pump, tubing of pinch valve and sealing of wash probe.The customer has not observed any further fliers post service.There is no sample available for in house testing.In house kit release was reviewed and no fliers were observed at the time the kit was released.The cause for the discordant afp results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Common Device Name: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8171216
• Report Number: 1219913-2018-00302
• Device Sequence Number: 13817915
• Product Code: LOJ
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K020806
• 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): 01/16/2019

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: 05/15/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 09370199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1