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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the elevated replicates of advia centaur xp ee2 is unknown.The customer noted that there were no related errors found with the system when the ee2 tests were run and the system maintenance is performed.Siemens continues to investigate.The performing quality control/taking corrective action section of the instructions for use states: "if the quality control results do not fall within the expected values or within the laboratory's established values, do not report results.Take the following actions: -verify that the materials are not expired.-verify that required maintenance was performed.-verify that the assay was performed according to the instructions for use.-rerun the assay with fresh quality control samples.-if necessary, contact your local technical support provider or distributor.".

Event Description

Customer reported elevated advia centaur xp enhanced estradiol (ee2) results for four replicates of a quality control using one lot of cuvettes compared to the quality control results obtained with a different lot of cuvettes.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp ee2 control results.

Manufacturer Narrative

Mdr 1219913-2017-00145 was filed on june 27, 2017 reporting elevated advia centaur xp enhanced estradiol (ee2) results for four replicates of a quality control using one lot of cuvettes compared to the quality control results obtained with a different lot of cuvettes.July 5, 2017 - additional information.Lot number, gtin, date of manufacture and expiration date of the advia centaur enhanced estradiol were not available at the time of the initial filing.Lot number: 31977037, gtin 00630414573342 date of manufacture: 12/12/2016, expiration date: 10/12/2017.The customer confirmed that the cuvettes were stored according to the manufacturer's storage temperature recommendations of -20c to 60c.Siemens is unable to investigate further because the cuvettes are no longer available.Several factors can attribute to imprecision with the estradiol assay including reagents, calibrations, control integrity, instrument performance.Siemens is unable to confirm that cuvettes are the cause of the imprecision seen at this site.

• Brand Name: ADVIA CENTAUR 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: 6671133
• MDR Text Key: 78585282
• Report Number: 1219913-2017-00145
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10491445
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 07/05/2017
• Supplement Dates FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1