MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR VITAMIN B12 (VB12); VITAMIN B12 RADIOASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 09/20/2022

Event Type  malfunction  

Event Description

The customer observed discordant elevated advia centaur vitamin b12 sample results on multiple patients.On repeat testing the samples with an alternate method, the results were lower.The initial results were reported to physician(s) who questioned the results.There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the discordant vitamin b12 results.

Manufacturer Narrative

An outside the united states customer observed discordant elevated advia centaur vitamin b12 sample results on multiple patients.On repeat testing the samples with an alternate method, the results were lower.Calibration and quality control (qc) have been within the specifications for vitamin b12.The instructions for use (ifu) for vitamin b12 under the interpretation of results section 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 healthcare diagnostics is investigating.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00387 on nov 08, 2022 reporting, an outside the united states customer observed discordant elevated advia centaur vitamin b12 sample results on multiple patients.On repeat testing the samples with an alternate method, the results were lower.Nov 22, 2022 additional information: the customer confirmed the sample type - serum.Samples were repeated the next day after the physician's complaint.Internal study samples were repeated immediately within 2 hours.The samples were stored at 2- 8 °c.The samples were centrifuged prior to rerun.All the samples are stored upright after centrifugation.A study was performed to rule out sample tube related issues.Sample inter tube variation is not observed.Samples processed from different tubes, internally correlated.The alternate method instrument is located in the same floor, 6 feet away from the advia centaur instrument.All the samples were checked before repeat and no issues were observed.All the samples are from primary as well as aliquot tube.Dec 15, 2022 additional information: siemens has reviewed all data provided.The calibration on all 4 of the customers advia centaurs are acceptable and near expect relative light units for lot: 281 and calibrator cc74.The bio-rad qc lot: 40400 is performing as expected on all 4 advia centaurs with customer data within acceptable performance of bio-rad unity data and package insert ranges.Customer performed precision studies that were acceptable.No product issue was noted after review of all of the vb12 performance data.Customer patient data was reviewed extensively, and a majority of vb12 patient samples showed an initially high result that decreased upon repeat.The region verified that the samples were tested within the 48 hr stability time period, centrifuged immediately prior to being run and remained upright.The quality of the specimen could potentially impact the performance of the atellica im vb12 assay.Cellular debris could potentially be responsible for the higher-than-expected vb12 results.When samples are centrifuged prior to testing and remain upright or allowed to settle for an extended period, the vb12 assay can be impacted resulting in lower values.Siemens recommends following all collection tube handling instructions provided by the manufacturer.Based on the data presented, siemens cannot rule out issues with specimen quality and preanalytical handling of samples for the cause for the discordant samples.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00387 on nov 08, 2022.Siemens filed the mdr 1219913-2022-00387 supplemental 1 on dec 16, 2022.On jan 11, 2023 additional information: an outside the united states customer observed discordant elevated advia centaur vitamin b12 sample results on multiple patients.On repeat testing the samples with an alternate method, the results were lower.Siemens has reviewed all data provided.The calibration on all 4 of the customers advia centaurs are acceptable and near expect relative light units for lot 281 and calibrator cc74.The bio-rad qc lot 40400 is performing as expected on all 4 advia centaurs with customer data within acceptable performance of bio-rad unity data and package insert ranges.Customer performed precision studies that were acceptable.No product issue was noted after review of all of the vb12 performance data.Customer patient data was reviewed extensively, and a majority of vb12 patient samples showed an initially high result that decreased upon repeat.The region verified that the samples were tested within the 48 hr stability time period, centrifuged immediately prior to being run and remained upright.The quality of the specimen could potentially impact the performance of the atellica im vb12 assay.Cellular debris could potentially be responsible for the higher-than-expected vb12 results.When samples are centrifuged prior to testing and remain upright or allowed to settle for an extended period, the vb12 assay can be impacted resulting in lower values.Siemens recommends following all collection tube handling instructions provided by the manufacturer.Based on the data presented, siemens cannot rule out issues with specimen quality and preanalytical handling of samples for the cause for the discordant samples.The customer can perform additional mixing studies to confirm the issue with sample quality and cellular debris.No product problem was identified.After multiple requests, siemens has not received a response as to whether the customer requires additional assistance.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR VITAMIN B12 (VB12)
• Type of Device: VITAMIN B12 RADIOASSAY
• 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: 15751240
• MDR Text Key: 305184996
• Report Number: 1219913-2022-00387
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 00630414177168
• UDI-Public: 00630414177168
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 01/25/2023

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 10309970
• Device Lot Number: 281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/22/2022; 01/11/2023
• Supplement Dates FDA Received: 12/16/2022; 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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