MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problem Mechanical Problem (1384)

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) after obtaining erratic ee2 results on quality controls (qc) on following daily cleaning procedure (dcp) performed on the instrument.A siemens customer service engineer (cse) was dispatched to the customer's site.After inspecting the instrument, the cse found a leak in the wash manifold valve drawer coming from the fitting tube with wash 1 cleaning solution.The cse cleaned up the liquid and repaired the tube fitting.The cse calibrated ee2 with a new pack of reagent and then ran qc along with the current one on board that generated low relative light unit (rlu), the results were satisfactory except for qc level 1 which obtained low rlu on the new pack.The customer requested the technical applications specialist (tas) to run master curve material (mcms) and run precision to validate these tests.The tas performed accuracy, precision and linearity on the ee2 assay, resulting acceptable.The cause of the discordant, falsely elevated ee2 results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated enhanced estradiol (ee2) results were obtained on patient samples on an advia centaur xp instrument.The initial results were reported to the physician(s).The samples were repeated on the same instrument, resulting lower.The samples were then repeated on an alternate advia centaur instrument, and the results matched the original instrument repeat results.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated ee2 results.

Manufacturer Narrative

The initial mdr 2432235-2017-00482 was filed on 21-august-2017.A siemens customer service engineer (cse) had returned at the customer's site on (b)(6) 2017: the cse installed a new separation manifold and all 4 aspirate probe pinch valves.The cse ran quality control (qc), resulting acceptable.Additional information (13-november-2017): a siemens headquarter support center (hsc) specialist evaluated the service information and determined that the wash manifold is essential for the accurate washing of cuvettes and incomplete washing due to a leak, can potentially lead to high discordant results as seen in this event.The cse performed the appropriate corrective action to resolve this issue.The cause of the discordant, falsely elevated ee2 results could not be determined.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; manufacturing limited; registration number: 8020888; chapel lane, dublin, swords, ; EI
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6806800
• MDR Text Key: 83133207
• Report Number: 2432235-2017-00482
• Device Sequence Number: 0
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1