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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the customer care center (ccc) and reported that discordant falsely elevated vitamin b12 (vb12) results for a patient were obtained on an atellica im 1600 instrument.Siemens performed troubleshooting.No issues were identified.The customer confirmed that the same readypack was used for all three results.The customer also confirmed that the results were all from the same primary tube and there was no agitation or mixing of the tube between the results.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens continues to investigate.

Event Description

An initial vitamin b12 (vb12) result for a patient was generated on an atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was repeated in duplicate on the same atellica im 1600 analyzer and both replicates were considered discordant, falsely elevated results.The sample was sent out to an alternate facility for testing and resulted 120 pmol/l which was reported to the physician(s), as the correct result.The initial result was also considered correct.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated, discordant results.

Manufacturer Narrative

The initial mdr 1219913-2021-00453 was filed on september 28, 2021.Additional information - november 8, 2021, siemens has investigated the outside the united states customer's observation of high discordant non-reproducible vitamin b12 (vb12) patient results on the atellica im compared to a repeat result and testing at an alternate site.A product issue was not identified.The rationale for this conclusion is based on the following investigation results: siemens has invesitgated non-reproducible elevated results.Samples were mixed/agitated and this resulted in an increased vb12 value.The vb12 result then decreased to the expected value when the sample is centrifuged or diluted.Additional testing was performed with freshly drawn serum gel tubes.The fresh drawn samples were spiked with cellular debris (white cells and platelets) which showed a significant increase in the vb12 dose value.Spiked samples were then re-centrifugated and allowed to settle overnight.Both resulted in a decreased vb12 dose value more similar to the initial dose obtained before spiking the samples.There is no evidence that a change in a specific reagent component was responsible for the discordant result.The same primary reagent pack p01327410071495 and ancillary dtt pack (a01372572618092) were used for the original and the first repeat result.The same calibration was used for each replicate of patient sample id (b)(6).Results of the internal investigation conducted by siemens indicates that the quality of the specimen could potentially impact performance of the atellica im vb12 assay.Cellular debris could potentially be responsible for the higher than expected vb12 results.Siemens recommends following all collection tube handling instructions provided by the manufacturer.Customer is operational.No further investigation is required.In section h6, investigation findings, and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM VIATMAIN B12 (VB12)
• Type of Device: RADIOASSAY, VITAMIN B12
• 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: 12540070
• MDR Text Key: 273571627
• Report Number: 1219913-2021-00453
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: 00630414600284
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 11/10/2021

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: 05/16/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 274
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1