MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) ASSAY; ENHANCED ESTRADIOL IMMUNOASSAY

Model Number N/A

Device Problems Calibration Problem (2890); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp enhanced estradiol (ee2) correlation study results obtained with the new calibrator lot (c3021) is unknown.Siemens is investigating.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

The customer had observed low advia centaur xp enhanced estradiol (ee2) quality control (qc) patient results with a new calibrator lot (c3021).A siemens representative performed an ee2 patient correlation study, and observed discordant low results.The customer continues to use the previous calibrator lot (c3020) and reagent kit lot.There was no report of patient treatment being altered or adverse health consequences due to the discordant advia centaur xp enhanced estradiol (ee2) correlation study results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00088 for low advia centaur xp enhanced estradiol (ee2) quality control (qc) and patient results with a new calibrator lot (c3021).On (b)(6) 2017 additional information: siemens has performed an internal investigation and has confirmed a negative bias for the advia centaur enhanced estradiol (ee2) on the advia centaur, advia centaur xp and advia centaur xpt systems when calibrating with calibrator 30 kit lots ending in 21 (c3021) as compared to calibrator 30 kit lots ending in 20 (c3020).Siemens issued ufsn cc 17-15.A.Ous (june 2017) and umdr cc 17-15.A.Us (june 2017) informing the customer of a negative bias for the advia centaur enhanced estradiol (ee2) on the advia centaur, advia centaur xp and advia centaur xpt systems when calibrating with calibrator 30 kit lots ending in 21 (c3021) as compared to calibrator 30 kit lots ending in 20 (c3020).This issue does not affect the advia centaur cp system.Instructions on actions to be taken are provided in the customer communication.No further investigation is required.

• Brand Name: ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) ASSAY
• Type of Device: ENHANCED ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole, MA 02032
• Manufacturer Contact: stephen perry ; 511 benedict avenue; tarrytown, NY 10591-5097 ; 5086604163
• MDR Report Key: 6473370
• MDR Text Key: 72553842
• Report Number: 1219913-2017-00088
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2017
• Device Model Number: N/A
• Device Catalogue Number: 10490889
• Device Lot Number: 07455036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1219913-06-07-2017-005-R
• Patient Sequence Number: 1