MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP BR (27.29); BR (27.29) IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant advia centaur xp br (ca 27.29) non-reproducible patient results.A siemens customer service engineer (cse) was dispatched to the customer site for system inspection.The cse performed a total service call and full system decontamination.The customer's quality control (qc) were within range prior to running the patient samples on (b)(6) 2020, however when qc was run the next day, it was 3sd out of range.The customer replaced the reagent pack, calibrated and reran qc, resulting within package insert ranges.The patient samples were repeated and resulted as expected.Based on the service activity, the customer replacing the reagent readypack, calibration and obtaining acceptable qc results, the potential cause is unknown.The customer does not require any further action on this issue as the reagent pack was replaced and expected results were obtained.A product non-conformance was not identified, and the system is operational.The instructions for use in the results interpretation section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instrument is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
Falsely elevated advia centaur xp br (ca 27.29) results were obtained on two patient samples and considered discordant compared to lower results when tested with new samples.The original samples had been previously tested at an alternate site (client), resulting lower.The discordant, br results were not reported to the provider(s).Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant, falsely elevated advia centaur xp br (ca 27.29) results.

• Brand Name: ADVIA CENTAUR XP BR (27.29)
• Common Device Name: BR (27.29) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10183487
• Report Number: 1219913-2020-00146
• Device Sequence Number: 19641911
• Product Code: MOI
• UDI-Device Identifier: 00630414196657
• UDI-Public: 00630414196657
• 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
• Report Date (Section B): 06/23/2020

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: 09/23/2020
• Device Model Number: N/A
• Device Catalogue Number: 10333349
• Device Lot Number: 246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1