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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant, falsely elevated advia centaur xp enhanced estradiol (ee2) result on a patient taking the medications letrozole tablets, zoladex (goserelin acetate sr depot) and mirena.Siemens is investigating.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
Discordant, falsely elevated advia centaur xp enhanced estradiol (ee2) neat (undiluted) and onboard (auto) dilution results were obtained on a patient sample.The elevated results were not reported to the physician(s).The customer performed repeat testing on three alternate estradiol test methods with the same patient sample (neat), all resulting lower.The lower alternate estradiol test results agreed with the clinical picture of this patient.The lower estradiol result was reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, falsely elevated advia centaur xp enhanced estradiol (ee2) results.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00378 initial report on (b)(6) 2021 for discordant, falsely elevated advia centaur xp enhanced estradiol (ee2) neat (undiluted) and onboard (auto) dilution results versus alternate methods.21-jul-2021.Additional information: the customer performed a manual (1:10) dilution of the patient sample, resulting high (7950 pg/ml).Siemens has completed the investigation.This investigation included a review of the medication taken by this patient.None of the medications are listed in the instructions for use (ifu) specificity table.The patient sample was treated with a heterophilic blocking tube (hbt) and then retested on the advia centaur xp.The advia centaur ee2 value did not decrease following hbt treatment.The sample was requested for an internal investigation, but the sample was not able to be returned.While the exact root cause of the falsely elevated advia centaur ee2 results from this patient is unknown, siemens cannot rule out a non-specific interferent.Immunoassays are subject to a number of interferences including those caused by endogenous antibodies.Interference can occur because of heterophile antibodies, anti-animal antibodies and auto antibodies.The interfering antibodies can give rise to a falsely high or less commonly a falsely low result.In this case, the erroneous result is recognized as being inconsistent with the patient's clinical picture.Different estradiol assays may use different antibodies and can show different cross reactivity.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.If the estradiol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.The customers advia centaur xp ee2 quality control (qc) was in range and no issues were noted with other patient samples.A product issue has not been identified during this investigation.The customer is operational.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion code were revised.

• Brand Name: ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2)
• Common Device Name: ENHANCED ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12176466
• Report Number: 1219913-2021-00378
• Device Sequence Number: 16377946
• Product Code: CHP
• UDI-Device Identifier: 00630414574646
• UDI-Public: 00630414574646
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2021
• Device Model Number: N/A
• Device Catalogue Number: 10491445
• Device Lot Number: 072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR