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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens performed an internal correlation between atellica im br lot 047243/cg47 and lot 047245/cg47.Ten samples ranging from 16.45-176 u/ml were tested and the average percent bias observed was 2.73%.Siemens continues to investigate.
Event or Problem Description
The customer observed a bias between two lots of atellica im 1600 br 27.29 (br) reagents on six patient samples.There are no reports that treatment was altered or prescribed due to the bias between atellica 1600 br results.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed initial mdr 1219913-2020-00171 on (b)(6) 2020.Additional information from (b)(6) 2020: poor patient correlation was observed with atellica im 1600 br 27.29 (br) between reagent lots 047243, and 047245.A correlation was performed by siemens, comparing br lot 047243/cg47 to br lot 047245/cg57.The average percent bias observed was 2.73%.The samples tested during the correlation are from throughout the assay range 16.45-176 u/ml.The samples used by the customer for their correlation were not from throughout the assay range,but ranged from 26.12-64.78 u/ml.The poor patient correlation results observed by the customer was not observed in siemens' internal testing.Siemens technical application specialist (tas) went to customer site and recalibrated with a new lot of reagent (lot 047249) and reran a patient correlation with acceptable results.Siemens is unable to rule out sample specific issue.Based on the investigation, no product problem was identified.The customer is operational.No further action is required.The result and conclusion codes have been updated to reflect the investigation results.Reference section h6 of this report for the updated codes.

• Brand Name: ATELLICA IM BR 27.29 (BR)
• Common Device Name: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10258139
• Report Number: 1219913-2020-00171
• Device Sequence Number: 14323770
• Product Code: MOI
• UDI-Device Identifier: 00630414598048
• UDI-Public: 00630414598048
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/24/2020

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: Health Professional
• Device Expiration Date: 08/04/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995477
• Device Lot Number: 243
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1