MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT VB12 ASSAY; VB12 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	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant vb12 results is unknown.The instrument is performing within specifications.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
Discordant advia centaur xpt vb12 (vitamin b12) results were obtained on samples from two patients.The results were discordant with the immulite 2000 xpi platform.The customer ran the patient samples on the same instruments and same run.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the vb12 discordant results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00244 on december 14, 2017.01/09/2018 additional information: there is no claim for the alignment of the advia centaur xpt vb12 assay to the immulite 2000 xpi vb12.Each platform utilizes different approaches to method comparisons and standardizations.The cause for the discordant advia centaur xp vb12 (vitamin b12) results is possibly due to the inherent differences in both assays and the way the assays were standardized.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XPT VB12 ASSAY
• Common Device Name: VB12 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7116945
• Report Number: 1219913-2017-00244
• Device Sequence Number: 13735954
• Product Code: CDD
• UDI-Device Identifier: 00630414177168
• UDI-Public: 00630414177168
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K993571
• 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): 01/11/2018

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: 04/24/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309970
• Device Lot Number: 83059240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1