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

Model Number	N/A
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer observed out-of-range qc results for the atellica im 1600 br (ca 27.29) assay, and subsequently installed a new reagent pack and recalibrated.Qc results were within specification following the reagent-pack change.The customer re-tested patient samples run since the last good qc results were obtained.Upon repeat testing, 6 samples produced results which were at least 30% lower than the original test results.The initial results (associated with the failed-qc observation) were considered discordant, and not used; the lower results from the repeat testing were reported to the physician.The customer reports that qc results are within range and that the system is operational following the change to a new reagent pack.Siemens is investigating.
Event or Problem Description
Discordant elevated atellica im 1600 br (ca 27.29) results were obtained for six (6) patient samples, as compared to lower results observed when the same samples were re-tested using new reagents.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant, falsely elevated atellica im 1600 br (ca 27.29) results.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2020-00417 on 16-oct-2020 to report discordant elevated atellica im 1600 br (ca 27.29) results.Additional information, 28-oct-2020: siemens has concluded the investigation.The customer reported result discordance and out-of-range qc results with atellica im 1600 br (ca 27.29) lot 249.Siemens performed onsite service on the affected instrument, and the customer reported that qc performance was within specifications after the reagent pack was replaced and recalibrated.The customer did not re-test the samples which produced the earlier discordant results.Based on the available information, siemens cannot rule out a possible issue with reagent pack or calibration.No product performance issue was 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)
• Common Device Name: BR (27.29) IMMUNOASSAY, PRODUCT CODE: MOI
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 10693395
• Report Number: 1219913-2020-00417
• Device Sequence Number: 3483129
• Product Code: MOI
• UDI-Device Identifier: 00630414598055
• UDI-Public: 00630414598055
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K982680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: No Information
• Device Expiration Date: 11/20/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995478
• Device Lot Number: 249
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1