MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM VITAMIN B12 (VB12); ATELLICA IM VB12

Model Number 10995714

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer observed an elevated atellica im vitamin b12 (vb12) result from a sample which was elevated compare to the repeat result and historical results.Interpretation of results of the instructions for use (ifu) states the following: " results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.

Event Description

Customer observed an elevated atellica im vitamin b12 (vb12) result for a patient sample compared to the repeat result and historical results.The result was reported and questioned by the physician.There were no reports that treatment was altered or prescribed or adverse health consequences due to the discordant elevated result.

Manufacturer Narrative

The initial mdr 1219913-2021-00507 was filed on december 17, 2021.Additional information - february 18, 2022.An outside the us customer observed an elevated atellica im vitamin b12 (vb12) result from a sample which was elevated compared to the repeat result and historical results.Siemens performed a study using becton dickinson (bd) serum and plasma lithium heparin gel separator tubes (sst & pst tubes).Testing included fresh drawn specimens, tested after initial centrifugation followed by mixing tubes for 30 minutes and re-centrifugation of the tubes.The results from this study replicated the observation of an increase in vb12 values after remixing bd pst lithium heparin tubes.Bd sst tubes did not show an increase in the vb12 values after being remixed.Plasma has higher cell and platelet content than serum.The cells and platelets are concentrated on or near the gel surface (buffy coat).After centrifugation mixing/agitation of plasma tubes should be avoided because it can lead to resuspension of components that were at on or near the gel surface.The atellica im xpt vb12 instructions for use (ifu) lists both serum and plasma as acceptable specimen types.The results from internal investigations verify that plasma and serum are suitable for use with the atellica im vb12 assay when tube manufacturer's ifu are followed.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.A potential product performance issue has not been identified.The customer's system is running within specification.Qc is running within range.The customer is operational.No further action is needed.In section h6, investigation findings, and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM VITAMIN B12 (VB12)
• Type of Device: ATELLICA IM VB12
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 13024551
• MDR Text Key: 287809518
• Report Number: 1219913-2021-00507
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 00630414600277
• UDI-Public: 00630414600277
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K993571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2022
• Device Model Number: 10995714
• Device Catalogue Number: 10995714
• Device Lot Number: 274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1