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

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	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a discordant elevated atellica im vitamin b12 (vb12) result for one patient.The initial result was reported to physician(s), who questioned the result.The same sample was tested on another atellica im analyzer, and the result was low.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant vitamin b12 (vb12) results.
Additional Manufacturer Narrative
An outside the united states customer obtained a discordant elevated atellica im vitamin b12 (vb12) result for one patient.The initial result was reported to physician(s), who questioned the result.The same sample was tested on another atellica im analyzer, and the result was low.The interpretation of results section of the atellica im vitamin b12 (vb12) instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens continues to investigate.
Additional Manufacturer Narrative
Initial mdr 1219913-2022-00437 was filed on dec 07, 2022 reporting an outside the united states customer observed an elevated atellica im vitamin b12 (vb12) result for one patient.Additional information - jan 11, 2023.Siemens has investigated the customer report of a discordant patient result on vitamin b12 (vb12) lot 282 on atellica im 1600 instrument (ih00442).The patient vb12 sample was initially tested on ih00442 and then retested on alternate atellica im module.The patient sample in question demonstrated a decrease in result when retested later.Siemens reviewed escalation data available.The instrument (ih00442) was serviced in response to the issues noted with the patient sample.The service engineer found errors in the cuvette loader, reagent loader and compartment, and with the sample probe.The sample probe and reagent loader were aligned along with the plunger being cleaned.Instrument was returned to service with acceptable performance.Sample was also noted by customer to have fibrin present.The customer also noted an issue with dtt ancillary reagent a01373203925515 which was used with the patient sample in question and qc was out of range.The customer had removed dtt ancillary reagent during life of reagent and reagent stability may have been compromised.Acceptable assay performance was resumed when the ancillary pack was replaced.Based on the information presented, siemens cannot rule out issues with specimen quality, ancillary being compromised or a hardware issue for the cause discordant patient results.Based on the investigation, no potential product issue is observed.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM VITAMIN B12 (VB12) ASSAY
• Common Device Name: VITAMIN B12 (VB12) ASSAY
• 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: 15932737
• Report Number: 1219913-2022-00437
• Device Sequence Number: 17782784
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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