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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a discordant elevated atellica im 1600 vitamin b12 (vb12) result on a patient sample using lot 285.The initial result was reported to the physician(s), who did not question the result.The sample was repeated on the same atellica im analyzer, and the result was lower.The lower result was considered as correct by the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant elevated vb12 patient result.
Additional Manufacturer Narrative
An outside the united states customer obtained a discordant elevated atellica im 1600 vitamin b12 (vb12) result on a patient sample using lot 285.The initial result was reported to the physician(s), who did not question the result.The sample was repeated on the same atellica im analyzer, and the result was lower.The lower result was considered as correct by the physician(s).Siemens investigation included an assessment of reagent, instrument, and sample data.The customer informed the local team that an operational failure occurred when preparing the ancillary dtt for vb12.The customer potentially may have insufficiently mixed the dtt reagent during preparation, allowed reagent to sit before placing in reagent compartment or diverged from appropriate volumes during manual reagent preparation resulting in discordant results as the reagent volume depletes.The customer should review proper preparation and handling of the dtt/releasing agent as directed in the preparing the reagents secton of the atellica im vitamin b12 (vb12) instructions for use (ifu), 10995437_en rev.02, 2019-08.The interpretation of results section of the atellica im vitamin b12 (vb12) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." based on the information presented, siemens cannot rule out issues with the ancillary reagent being compromised for the cause discordant patient result.The customer is currently operational.

• Brand Name: ATELLICA IM VITAMIN B12 (VB12)
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; 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: 17288656
• Report Number: 1219913-2023-00134
• Device Sequence Number: 15025426
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: 00630414600284
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K993571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 285
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/10/2023
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown