MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM BR 27.29 (BR); SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Model Number N/A

Device Problem High Test Results (2457)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.Siemens provided br 27.29 master curve material for troubleshooting.The master curve material results were high out of range.

Event Description

On (b)(6) 2020, two discordant elevated results were observed using the br 27.29 assay on the atellica im 1300 analyzer, when compared to the br 27.29 assay on the advia centaur xp.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of the elevated atellica im 1300 br 27.29 results.

Manufacturer Narrative

Siemens filed the initial mdr on 2020-07-10 to report discordant, elevated results obtained using the br 27.29 assay on the atellica im 1300 analyzer, when compared to the br 27.29 assay on the advia centaur xp.Additional information received on september 2, 2020: investigation was completed 2020-09-02.On (b)(6) 2020, the customer observed two non-reproducible discordant results from the customer's atellica im system as compared to third-party reference testing.The system log files were reviewed and there was no evidence of a possible hardware related cause for the non-reproducible results.On-site testing showed some levels of master curve material (mcm) were out of range.The account moved to a new lot of reagent and calibrator; subsequent mcm testing produced results within specification.The affected patient samples could not be re-tested with the new reagent lot and calibrator lot as there was no more sample available.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the non-reproducible results.Pre-analytical factors or sample specific issues cannot be ruled out.Based on the information provided, no product problem was identified.The customer is operational.No further investigation is planned.In section h6, the health effect - clinical code, health effect - impact code and the component code were added.The medical device problem code and the type of investigation codes remained the same.The investigation findings code and the investigation conclusions codes were revised.

• Brand Name: ATELLICA IM BR 27.29 (BR)
• Type of Device: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown, ny
• MDR Report Key: 10257263
• MDR Text Key: 206380124
• Report Number: 1219913-2020-00169
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995477
• Device Lot Number: 245
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1