MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 125II ASSAY; CA 125II 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 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the lower advia centaur xp ca 125ii neat results.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." the instruction for use (ifu) under the limitation section states the following: "note: do not interpret levels of ca 125 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed ovarian carcinoma frequently have levels of ca 125 within the range observed in healthy individuals.Elevated levels of ca 125 can be observed in patients with nonmalignant diseases.Measurements of ca 125 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." mdr 1219913-2017-00260 was filed on 1/05/2018 for results from the same patient tested on a different day, and mdr 1219913-2017-00260 supplemental report 1 was filed on 01/09/2018 for additional information and correction.

Event Description

Low advia centaur xp ca 125ii neat results were obtained on two samples from the same patient when run in duplicate the following day ((b)(6) 2017).The low neat results were considered discordant compared to higher ca 125ii dilution results.There are no reports that patient treatment was altered or prescribed or adverse health consequences due to the low advia centaur xp ca 125ii results.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00262 was filed conservatively due to limited information on 01/09/2018 for a low advia centaur xp ca 125ii repeat result.02/18/2018 - additional information: the patient sample was returned for further testing by siemens.An over recovery upon dilution was observed, and that heterophilic antibodies are not causing the over recovery upon dilution.(b)(6).Siemens performed an internal investigation after receiving reports of dilution over-recovery with certain patient samples.The complaint investigation has demonstrated that the advia centaur ca 125ii assay performance remains unchanged.The assay linearity was verified as well as the upper limit of normal stated in the assay instructions for use.The investigation concluded: the over-recovery of dilutions is a result of patient variability and: over-recovery of dilutions is common with mucin/mucin-like immunoassays.Ca 125 is a mucin-like glycoprotein."nonlinear dilution with increased recovery of the antigen is common in immunoassays for mucins.This is probably due to a variety of factors such as the presence of high levels of anti-carbohydrate antibodies in serum, which generates complexes, the inherent property of mucins to aggregate and disaggregate into a range of molecular species, and other matrix-related effects."(1) reference: (1) wild d, ed.The immunoassay handbook.4th ed.Oxford, uk: elsevier science; 2013:842.The following customer notifications were released on 2018-02-21: cc 18-01.A.Us, titled "information regarding advia centaur ca 125ii assay dilution recovery" was released for us customers.Cc 18-01.A.Ous, titled "information regarding advia centaur ca 125ii assay dilution recovery" was released for customers outside the us (ous).The purpose of this communication is to inform the customer that upon dilution, some patient samples may exhibit over-recovery outside of the representative data provided in the advia centaur ca 125ii assay instructions for use.Investigations performed by siemens healthcare diagnostics demonstrated dilution recoveries up to 140% with certain patient samples.Studies indicate the dilution over-recovery is sample specific.This issue has negligible severity and overall risk to health.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." the instruction for use (ifu) under the limitation section states the following: "note: do not interpret levels of ca 125 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed ovarian carcinoma frequently have levels of ca 125 within the range observed in healthy individuals.Elevated levels of ca 125 can be observed in patients with nonmalignant diseases.Measurements of ca 125 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." mdr 1219913-2017-00260 was filed for an initial low result on the same patient, mdr 1219913-2017-00260 supplemental report 1 for a correction and additional information, and mdr 1219913-2017-00260 supplemental report 2 for additional information.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00262 was filed conservatively due to limited information on 01/09/2018 for a low advia centaur xp ca 125ii repeat result, and mdr 1219913-2017-00262 supplemental report 1 on 02/26/2018 for additional information.03/02/2018 - additional information: corrections and removal report #1219913-02/18/2018-001-c has been added.Mdr 1219913-2017-00260 was filed for an initial low result on the same patient, mdr 1219913-2017-00260 supplemental report 1 for a correction and additional information, mdr 1219913-2017-00260 supplemental report 2, and mdr 1219913-2017-00260 supplemental report 3 for additional information.

• Brand Name: ADVIA CENTAUR XP CA 125II ASSAY
• Type of Device: CA 125II IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7176602
• MDR Text Key: 96820458
• Report Number: 1219913-2017-00262
• Device Sequence Number: 1
• Product Code: LTK
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (y/n): N
• PMA/PMN Number: K020828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2017
• Device Model Number: N/A
• Device Catalogue Number: 10310443
• Device Lot Number: 015173
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1219913-02/18/2018-001-C
• Patient Sequence Number: 1