MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT VB12; VITAMIN B12 IMMUNOASSAY

Model Number 10309970

Device Problem High Test Results (2457)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating the cause of the discordant vb12 result.The instructions for use in the interpretation of results section states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instructions for use in the limitations section states: "preservatives, such as fluoride and ascorbic acid interfere with the advia centaur vb12 assay.Excessive exposure to light may alter vitamin b12 values.".

Event Description

A customer obtained a falsely elevated result on a patient sample using advia centaur xpt vitamin b12 (vb12).Quality control results were within acceptable range.The physician questioned the initial result and the sample was retested at the request of the physician.The sample was refrigerated and repeat testing was performed on the refrigerated sample, at room temperature and re-centrifuged.The same instrument was used for the repeat testing.Lower results were obtained for these 3 conditions.A corrected report issued, but it is unknown if all 3 repeat results were provided in the corrected report.Patient treatment was not altered or prescribed based on the discordant vb12 results.There was no report of adverse health consequences due to the discordant vb12 results.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2020-00152 on 06/26/2020.Additional information from 07/06/2020 through 07/29/2020: customer provided additional patient results and explained that they are now running vb12 in duplicate on 2 advia centaur xpt systems because they have observed a difference between the measurements.Siemens reviewed the additional data and the following observations were made: both instruments used for testing have a degree of variation between the vb12 results.There is no definitive pattern or direction of replicate bias over time.In addition, this data shows both increasing and decreasing vb12 values, which does not align with the original complaint description, where repeat results were consistently lower than the initial results.Customer provided data from a study performed at their site and provided information about the centrifuges used.The centrifuges on the track are from hettich.(type: unknown).Rcf: 3000g.Temp: 22c.Tim: 10.2 min (incl start and brake time).The centrifuge off-track is from hettich.(type rotanta 460r).Rcf: 3001g.Temp: 22c.Time: 10 min.Brake: 50%.Siemens continues to investigate the issue by reviewing the additional data provided.

Manufacturer Narrative

Additional information: 9/18/2020: the patients did not receive vitamin b 12 supplementation.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2020-00152 on june 26, 2020, mdr 1219913-2020-00152 supplemental 1 report on july 30, 2020 and mdr 1219913-2020-00152 supplemental 2 report on october 19, 2020.Additional information - 02/24/2021: siemens performed a sample tube study using fresh drawn samples collected in 3 different tube types; bd vacutainer serum separation tubes (sst), bd vacutainer plasma separation tubes (pst) and plasma without gel separator.The tubes were allowed to clot and were centrifuged according to tube manufacturer recommendations.The tubes were then be tested under different conditions: poured off into secondary container, re-centrifuged, re-mixed and repeated after 4 hrs.The plasma samples showed an increase in vb12 dose following mixing with all 5 samples recovering >amr for neat dose recovery and an increased, but on curve, recovery for the 1:2 on board diluted samples.After re-centrifugation, all samples returned to the initial dose.The serum samples showed no significant change to vb12 dose recovery after mixing for either neat or diluted samples.The results from this study replicated the customer's observation of an increase in vb12 values after remixing plasma tubes.The results indicate that transit of these samples may be contributing to an insoluble interferent that can be suspend by mixing/handling, and mitigated by settling and centrifugation.Siemens continues to investigate.

Manufacturer Narrative

Siemens healthcare diagnostics has filed the following reports for this event: mdr 1219913-2020-00152 initial report on june 26, 2020 mdr 1219913-2020-00152 supplemental 1 report on july 30, 2020 mdr 1219913-2020-00152 supplemental 2 report on october 19, 2020 mdr 1219913-2020-00152 supplemental 3 report on march 22, 2021 additional information - 05/14/2021 siemens has concluded the investigation for a customer observation of high discordant non-reproducible plasma sample patient results on the advia centaur xpt vitamin b12 (vb12) assay, where the initial vb12 patient results were higher than the repeat results.Siemens performed studies using becton dickinson (bd) serum and plasma lithium heparin gel separator blood collection tubes (sst & pst tubes).Testing included fresh drawn specimens tested after initial centrifugation, after mixing tubes for 30 minutes and again after re-centrifuging the tubes.The results from this study replicated the customer's 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.Siemens contacted the tube manufacturer who provided sample handling information outlining the difference between serum and plasma sample collection tube types.The following information was noted: 1.Plasma has higher cell and platelet content than serum.2.The cells and platelets are concentrated on or near the gel surface (buffy coat).3.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 advia centaur xpt vb12 instructions for use currently lists both serum and plasma as acceptable specimen types.Siemens concluded that the results from the internal studies verify that plasma and serum are suitable for use with the advia centaur xpt vb12 assay when tube manufacturer's instructions for use are followed.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.The customer states the system is running within specification.Quality control (qc) is performing within range.A product performance problem has not been identified.No further evaluation of the device is required.Section h6 of this report has been updated to (1) reflect the changes in the emdr form since filing of the initial report (06/26/2020) and (2) update the investigation finding and investigation conclusion codes based on the investigation results.

• Brand Name: ADVIA CENTAUR XPT VB12
• Type of Device: VITAMIN B12 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10204145
• MDR Text Key: 222189556
• Report Number: 1219913-2020-00152
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 00630414177168
• UDI-Public: 00630414177168
• Combination Product (y/n): N
• PMA/PMN Number: K993571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2021

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: 07/02/2020
• Device Model Number: 10309970
• Device Catalogue Number: 10309970
• Device Lot Number: 258
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/06/2020; 09/18/2020; 02/24/2021; 05/14/2021
• Supplement Dates FDA Received: 07/30/2020; 10/19/2020; 03/22/2021; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1