MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS, INC ADVIA CENTAUR XP VITAMIN B12 (VB12) ASSAY; VITAMIN B12 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	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the non-reproducible, elevated advia centaur xp vb12 result is unknown.Based on review of instrument qc recovery, qc precision, instrument inspection, and repeat of other patients run at the same date and time and with the same reagent lot and ancillary reagent lot as the discordant patient sample, siemens concludes that the original advia centaur xp vitamin b12 result which was reported as 442 pmol/l, and repeated as161 pmol/l, was an isolated issue with no conclusive root cause.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
The doctor questioned an elevated advia centaur xp vitamin b12 (vb12) result that did not agree with the clinical picture or repeat testing.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp vb12 result.

• Brand Name: ADVIA CENTAUR XP VITAMIN B12 (VB12) ASSAY
• Common Device Name: VITAMIN B12 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7270721
• Report Number: 1219913-2018-00082
• Device Sequence Number: 1893356
• Product Code: CDD
• UDI-Device Identifier: 00630414177175
• UDI-Public: 00630414177175
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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: 08/21/2018
• Device Model Number: N/A
• Device Catalogue Number: 10330218
• Device Lot Number: 15095241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1