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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 11/22/2022

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 308186199
• Report Number: 1219913-2022-00437
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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