MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM BR 27.29 (BR); BR (27.29) IMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report erratic/high atellica im br 27.29 (br) quality control (qc) and high patient recovery results with atellica im sn (b)(4).A siemens customer service engineer (cse) was sent to the customer site for system inspection.The cse performed a preventative maintenance (pm) and replaced the probe arm during the pm.The cse performed alignments while onsite for an unrelated issue.Siemens is investigating.The instructions for use (ifu) under the performing quality control and taking corrective action section states the following: "for quality control of the atellica im br assay, use an appropriate quality control material of known analyte concentration with at least 2 levels (low and high) at least once during each day that samples are analyzed.Use the quality control material in accordance with the quality control instructions for use.A satisfactory level of performance is achieved when the analyte values obtained are within the expected control interval for the system or within your interval, as determined by an appropriate internal laboratory quality control scheme.Follow your laboratory's quality control procedures if the results obtained do not fall within the acceptable limits.If the quality control results do not fall within the assigned values, do not report results.Perform corrective actions in accordance with established laboratory protocol." the instructions for use (ifu) under the interpretation of results states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the instructions for use (ifu) under the warning section states the following: "do not use the atellica im br assay as a screening test or for diagnosis.Normal levels of ca 27.29 do not always preclude the presence of disease.Note: do not interpret levels of ca 27.29 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 27.29 within the range observed in healthy individuals.Additionally, elevated levels of ca 27.29 can be observed in patients with nonmalignant diseases.Measurements of ca 27.29 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".

Event Description

Falsely elevated, atellica im br 27.29 (br) results were obtained on six patient samples as compared to lower results observed when the same samples were re-tested with an alternate atellica im system.The customer had observed erratic/high quality control (qc) results and performed a patient result lookback verification.The lower repeat br results on the alternate atellica im system were reported as the correct results to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, atellica im br 27.29 (br) results.

Manufacturer Narrative

Siemens filed mdr 1219913-2021-00424 initial report on 20-aug-2021 for discordant, falsely elevated, atellica im br 27.29 (br) results obtained on patient samples.On 25-aug-2021: additional information: the replacement of the reagent probe 1 resolved the erratic/high quality control (qc) and discordant br patient results.The customer had patient samples that recovered higher with the atellica im br (ca 27.29) assay on atellica im s/n (b)(6) than when they were repeated on atellica im s/n (b)(6).A siemens customer service engineer (cse) replaced the reagent probe 1, after which the issue was resolved.If the reagent probe was not delivering sufficient reagent or was contaminating the reagent it could potentially cause high results as the atellica im br (ca 27.29) assay is a competitive (non-direct) assay.The potential cause of the discrepant patient results observed by the customer when using the atellica im br (ca 27.29) assay on atellica im s/n (b)(6) was an issue resolved with routine instrument troubleshooting.Based on the investigation, a product problem was not identified.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM BR 27.29 (BR)
• Type of Device: BR (27.29) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12350713
• MDR Text Key: 267919521
• Report Number: 1219913-2021-00424
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414598048
• UDI-Public: 00630414598048
• Combination Product (y/n): N
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995477
• Device Lot Number: 257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1