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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports discordant (depressed) results obtained with atellica im br 27.29 (br) lot 270.The customer had 4 samples that recovered < 9 u/ml (below the assay measuring interval) when initially tested with atellica im br lot 270, but when repeated with lot 270 and the same analyzer on the same day, they recovered higher.Due to the discrepant results the analyzer was evaluated, and sample probe pressure errors (s03 600 03 23) was observed.Siemens service engineer replaced the fluid sense delivery assembly, pressure sensor, related tubing and flushed sample probe plunger with methanol.A review of autocheck data showed the secondary vacuum was running high, so the secondary vacuum regulator was replaced.After service, there have been no additional reports of non-reproducible discordant br results.Siemens also reviewed the trace logs for the discrepant br samples and there was no other evidence of a hardware issue impacting sample or reagent delivery.The reagent packs and calibration that generated the low patient results had acceptable quality control (qc) recovery less than 2 hours before the discrepant br results were generated.The primary reagent pack was not removed and reloaded onto the analyzer.The packs and calibration also generated a result of 420 u/ml about the same time as the low results, so there is no evidence the discrepant br results were due an issue with the reagent packs or calibration.The customer is operational, and the reported issue is resolved after routine troubleshooting standard service actions.
Event or Problem Description
The customer reports discordant (depressed) results obtained with atellica im br 27.29 (br) lot 270.The samples were retested on the same instrument with a different reagent pack of the same lot number and results were higher and considered correct based on the clinical history of the patients.The initial low results were not reported.The retest results were reported as correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.

• 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 ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 20222976
• Report Number: 1219913-2024-00410
• Device Sequence Number: 18074317
• Product Code: MOI
• UDI-Device Identifier: 00630414598055
• UDI-Public: (01)00630414598055(10)99012270(17)241113
• Combination Product (Y/N): N
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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: 11/13/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995478
• Device Lot Number: 99012270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 10/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown