MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT CA19-9; CA19-9 IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.The full context of the scenario above is unknown (e.G.Rationale for testing on 3 platforms, which results would be considered accurate, whether patients were re-baselined prior to implementation of a new tumor marker assay, etc).It is well known for tumor markers that results from different platforms/assays cannot be used interchangeably and this limitation is expressly stated in siemens ifus for tumor marker assays.The instructions for use states: "warning the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values.The advia centaur ca 19-9 assay is based on the 1116-ns-19-9 antibody available through agreement with fujirebio diagnostics, inc.Assays using antibodies other than 1116-ns-19-9 may give different results." "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens has requested additional information mdr 1219913-2020-00104 was filed for samples with collection date (b)(6) 2020.Mdr 1219913-2020-00105 was filed for samples with collection date (b)(6) 2020.Mdr 1219913-2020-00106 was filed for samples with collection date (b)(6) 2020.Mdr 1219913-2020-00108 was filed for samples with collection date (b)(6) 2020.

Event Description

A customer is questioning advia centaur xpt ca19-9 results for multiple patient samples tested with one reagent lot.This customer transitioned from immulite to the advia centaur xpt ca19-9 method.A patient correlation study was performed at the customer site during the transition; customer observed acceptable correlation results.The customer then observed discordant low advia centaur xpt ca19-9 results when they began reporting patient results.The customer provided atellica im ca19-9 results for troubleshooting.The customer is not questioning the atellica im ca19-9 results.There is no indication that patient treatment was prescribed, delayed or altered.There was no report of adverse health consequences due to the discordant ca19-9 results.

Manufacturer Narrative

Siemens filed mdr 1219913-2020-00107 on 04/10/2020.Additional information 05/08/2020: customer informed physicians regarding the changing of methods from immulite to advia centaur xpt before the go live date.Additional information 05/18/2020: investigation complete.Siemens reviewed the complaint information provided to determine probable root cause.Qc was in range, indicating the methods are in control and the root cause is sample related, including reagent epitope binding to the sample.The original method comparison performed during advia centaur xpt install at the customer site demonstrated a slope of 0.985 between the methods on patient samples, however it was determined that these were not all native samples but were control material and spiked/contrived samples.Siemens reviewed the release data of the advia centaur xpt and immulite kit lots used by the customer for comparisons and there was no bias observed that would account for the patient and survey sample biases observed by the customer.Siemens performed a study with 30 patient samples tested in duplicate on advia centaur xp and immulite (advia centaur doses ranged from 14.14 to 142.615 u/ml).Deming regression analysis of the samples on immulite vs advia centaur xp demonstrated a slope of 2.99 and r value of 0.647.There were 10 samples that produced a bias approximately >50% higher on immulite vs advia centaur xp, which were then treated with heterophile binding tube (hbt) and repeated.The results did not change with hbt treatment indicating there is no heterophile antibody present causing this elevation.Siemens cannot rule out a non-specific interferent, i.E., drugs, nutritional supplements and/or herbal medicine in the blood causing this elevation.No additional information is available for these samples as they were obtained from a sample bank.Approximately 30% of the samples tested by siemens in the investigation would not be concordant based on each methods cutoff/reference range: immulite 95th percentile of observed results =18.4 u/ml (upper limit of normal samples 33 u/ml); advia centaur xp/xpt ca15-3 99th percentile of observed results = 37 u/ml.The ca19-9 assays on advia centaur xp/xpt and immulite are not standardized the same way; they are both standardized to an internal standard and there is no claim that results will match.Per the advia centaur xp/xpt instruction for use: "the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values.Results of the assays should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." based on the investigation results, no product performance issue was confirmed.The method code, result code and conclusion code have been updated to reflect the additional information.Reference section h6 of this report for the updated codes.Mdr 1219913-2020-00104 was filed for samples with collection date 03/02/2020.Mdr 1219913-2020-00105 was filed for samples with collection date 03/03/2020.Mdr 1219913-2020-00106 was filed for samples with collection date 03/05/2020.Mdr 1219913-2020-00108 was filed for samples with collection date 03/09/2020.

• Brand Name: ADVIA CENTAUR XPT CA19-9
• Type of Device: CA19-9 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9950941
• MDR Text Key: 195127856
• Report Number: 1219913-2020-00107
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414461311
• UDI-Public: 00630414461311
• Combination Product (y/n): N
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 457
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1