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	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated atellica im vitamin b12 (vb12) result which was discordant relative to repeat testing while using lot 296.An initial elevated result was obtained for one (1) patient sample.The initial elevated result was reported to the physician who questioned the result.The sample was tested while quality control (qc) was out of range.As a result, the same sample was retested on the original analyzer after qc recovered within laboratory established ranges and obtained a lower result.The lower result was considered correct and issued on the corrected report to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
A customer from the united states reported observation of an elevated atellica im vitamin b12 (vb12) result which was discordant relative to repeat testing.Siemens healthcare diagnostics has concluded investigation of the event.Siemens review of assay quality control (qc) data showed out of range results before and after patient testing.The qc issue was resolved by performing recalibration of the assay.Return of the patient sample for investigation is not warranted, as the discordant results were not reproducible.Based on the available information, a specific cause for the discordant results was unable to be determined.A product problem was not identified.The issue was resolved by routine troubleshooting.The customer is operational, and there are no residual issues.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 20144526
• Report Number: 1219913-2024-00401
• Device Sequence Number: 8397360
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: (01)00630414600284(10)10127296(17)250521
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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: 05/21/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 10127296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 06/21/2024
• 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