MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

The cause in the difference in the patient's result between ready packs of advia centaur cp ee2 is unknown.Siemens reviewed the storage and handling of the reagents with the customer.The customer noted that he uses a single 100 test ready pack of advia centaur ee2 every 3 to 4 days.The customer has not noticed any precipitate or parama gentic particles (pmp) coming out of solution while the reagent is on board the system.The system is not shut down for any extended periods of time and the door on the system is not left open.The ready packs are stored refrigerated and in the dark.Ready packs are mixed by hand before being loaded on the advia centaur cp.The customer has used this lot of reagent since (b)(6) 2016 and did not notice any issues until (b)(6) 2017.The customer will continue to monitor qc.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

Customer observed an advia centaur cp enhanced estradiol (ee2) result that was higher upon repeat testing.The patient results were not reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the non-reproducible advia centaur cp ee2 results.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00084 regarding an observation of an advia centaur cp enhanced estradiol (ee2) result that was higher upon repeat testing with a different readypack of reagents.On april 28, 2017 - additional information: the customer states that issue is ongoing.The customer will see lower recovery as the readypack ages and volume dips below 25 tests in the readypack.He places new readypack on board and qc will go back up.The customer reported that they noted this with reagent lot 036 as well as reagent lot 035.The customer provided the following data: (b)(6).Siemens continues to investigate the issue with the customer.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00084 regarding an observation of an advia centaur cp enhanced estradiol (ee2) result that was higher upon repeat testing with a different readypack of reagents.Mdr 1219913-2017-00084 supplemental report 1 was filed on april 28, 2017 with additional data.June 07, 2017 - additional information: the customer performed a precision study using advia centaur cp enhanced estradiol reagent lot 036 and master curve material.Three replicates of the mcms were run with a fresh pack and duplicates were resulted with an ee2 a pack that only had 35 tests remaining.Mcm 1: 5 replicates mean all were <11 cv 6.54% mcm 2: 5 replicates, mean 66 , cv 4.34%.Mcm 3: 5 replicates, mean 202, cv 1.67%.Mcm 4: 5 replicates, mean 468, cv 1.59%.Mcm 5: 5 replicates, mean 1907, cv 3.45%.Mcm 6: 5 replicates, mean >3000, cv 1.94%.Mcm on board x5 dilution: 5 reps, mean 2179 , cv 3.06%.Mcm ranges 44935: level 1 <32.1 level 2 48.8 - 81.3.Level 3 129 - 215.Level 4 354 - 590.Level 5 1222 - 2036.Level 6 > 2262.The five mcm replicates results acceptable and indistinguishable.Precision is acceptable.Since the complaint was received, service has been on-site.Service replaced reagent and sample probes and dilutors.Following service, estradiol precision was checked using master curve material.Results obtained on a fresh vs.Low volume pack are consistent.Performance of the estradiol assay at this account is acceptable following service.A product issue was not identified.The customer reported that no doctors questioned any patient results and there were no corrected reports or a delay in reporting results.No further investigation required for this incident.

• Brand Name: ADVIA CENTAUR CP ENHANCED ESTRADIOL (EE2) ASSAY
• 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: 6508279
• MDR Text Key: 73345892
• Report Number: 1219913-2017-00084
• 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,Followup
• Report Date: 07/06/2017

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: 04/29/2017
• Device Model Number: N/A
• Device Catalogue Number: 10490889
• Device Lot Number: 73438035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/20/2017
• Supplement Dates Manufacturer Received: Not provided; 06/07/2017
• Supplement Dates FDA Received: 05/15/2017; 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1