MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2); 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 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens performed internal testing which showed a similar bias between calibrator 30 lots ending in 20 and 21.Siemens continues to investigate the issue.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." advia centaur calibrator 30 kit lots ending in 21.Udi (b)(4).Expiry date march 08 2018.Date of manufacture november 08, 2016.

Event Description

Customer observed low quality control results for advia centaur xp enhanced estradiol (ee2) when moving to a new lot of calibrator.Low results were observed for patient samples when compared to results obtained with a previous lot of calibrator.Initial results were reported to the physician but there are no reports that treatment was altered or prescribed or adverse health consequences due to the low advia centaur enhanced estradiol results.

Manufacturer Narrative

Mdr 1219913-2017-00076 was filed on april 7, 2017 reporting low quality control results for advia centaur xp enhanced estradiol (ee2) when moving to a new lot of calibrator.Low results were observed for patient samples when compared to results obtained with a previous lot of calibrator.Siemens healthcare diagnostics has performed an internal investigation and confirmed a negative bias for 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' internal investigation has determined that samples with estradiol concentrations of approximately 35 pg/ml (128 pmol/l) and lower exhibit a % bias greater than the expected historical performance of the product when comparing c3021 to c3020.Results observed indicate that as estradiol concentrations increase, the % biases observed become less pronounced.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)
• Type of Device: ENHANCED ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 6472688
• MDR Text Key: 72412702
• Report Number: 1219913-2017-00076
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

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: 03/16/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2017
• 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