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

Model Number N/A

Device Problems High Test Results (2457); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.Calibration data was valid and acceptable.Quality control (qc) data was within 2sd of peer data and within customer ranges, but displayed a negative bias very close to the 2sd.The instructions for use states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

A customer obtained discordant high advia centaur xp br (ca 27.29) results for patient samples that were tested on the same day.The results were reported to the physician, who questioned the results.The patient samples were retested and the retest results correlated to patient history.Corrected reports were issued.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant br (ca 27.29) results.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr 1219913-2020-00091 on 03/18/2020.Additional information 04/01/2020: siemens investigated a customer complaint for multiple non-reproducible discordant patient results using advia centaur xp br reagent lot 240.The customer stated that they have had to calibrate multiple times due to the quality control drift.The account declined service from siemens.The internal engineer replaced some parts and the water filter.The system is running with no further issues with the advia centaur xp br immunoassay.The customer declined to provide any further details and is not willing to provide any further information regarding this escalation.Based on the information provided, no product problem was identified.Assay and system are operational.No further investigation required.In section h6, device, method, results and conclusion codes were updated to reflect the additional information.

• Brand Name: ADVIA CENTAUR XP BR (CA 27.29)
• Type of Device: BR (CA 27.29) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9848963
• MDR Text Key: 207768112
• Report Number: 1219913-2020-00091
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414196664
• UDI-Public: 00630414196664
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: N/A
• Device Catalogue Number: 10334837
• Device Lot Number: 047240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1