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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

The customer from outside the united states reports observation of discordant elevated multiple patient(s) sample results for vitamin b12 (vb12) assay, lot 290 when tested with atellica im 1600 analyzer.The initial results were not reported to the physician(s).The samples were repeated on multiple atellica im analyzers and lower results were obtained.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 healthcare diagnostics is investigating.

Event Description

The customer observed discordant elevated multiple patient(s) sample results for vitamin b12 (vb12) assay, lot 290 when tested with atellica im 1600 analyzer.The initial results were not reported to the physician(s).The samples were repeated on multiple atellica im analyzers and lower results were obtained.There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the observed elevated vitamin b12 (vb12) results.

Manufacturer Narrative

Initial mdr 1219913-2023-00157 was filed on aug 07, 2023.Additional information ¿ sep 06, 2023: the customer from outside the united states reported the initial issue as multiple discordant patient results on vitamin b12 (vb12) on atellica im 1600 instrument (ih0600).Siemens investigation included an assessment of reagent, instrument, and sample data.Siemens reviewed all data provided in escalation documentation to include quality control (qc), calibration, and patient sample results.Reagent issues were unable to be ruled out based on review of quality control (qc) which showed recovery was not within acceptable ranges for the reagent pack and ancillary pack combination used on with one of the patient samples (lot 290 p01329010164975 /2194 a01372194034704).Siemens reviewed the reagent and ancillary usage during the reported discordant samples, it was found that multiple packs of reagent and ancillary reagent were in use on this atellica im.Due to multiple reagent packs in use at the time of the discordant results and quality control (qc) out of range, siemens is unable to verify appropriate handling of vb12 reagent packs during the onboard stability of the reagent.Siemens also cannot rule out preanalytical handling of the patient samples as the cause of the discordant patient results at the customer site.Multiple patient samples were run before and after the samples in question on the same reagent and ancillary packs without any error or discordant results.There is a potential that when a customer 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, discordant results may occur.The customer should review proper preparation and handling of the dtt/releasing agent as directed in the atellica im vb12 information for use (ifu).Return of the patient sample for further investigation is not warranted because discordant results were not reproducible.The issue was resolved with routine troubleshooting.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM VITAMIN B12 (VB12) ASSAY
• Type of Device: 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: 17470207
• MDR Text Key: 321530056
• Report Number: 1219913-2023-00157
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: 00630414600284
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/25/2023

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: 01/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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