MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT CA 19-9 ASSAY; IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN,

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 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

The customer observed correlation differences of results between the advia centaur xpt ca 19-9 assay compared to an alternate ca 19-9 test method (tosoh) previously used by the customer.The customer tested the patient samples on a second alternate ca 19-9 test method (beckman) which produced higher results compared to the advia centaur xpt ca 19-9 assay.There are no apparent issues with the customer's advia centaur xpt ca 19-9 assay calibrations.The patient samples are not available for further investigation.The instruction for use (ifu) under the warning section states the following: "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 instruction for use (ifu) under the intended use section states the following: "the advia centaur® ca 19-9 assay is an in vitro immunoassay for the quantitative measurement of the ca 19-9 tumor-associated antigen, in human serum, using the advia centaur, advia centaur xp, and advia centaur xpt systems.This assay is indicated for the serial measurement of ca 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas.The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum ca 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort.Ca 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined." the instrument is performing within specifications.No further evaluation of the device is required.There were other patient correlation runs performed where the advia centaur xpt results were lower (refer to mdr 1219913-2017-00231, mdr 1219913-2017-00232, mdr 1219913-2017-00233, and mdr 1219913-2017-00234).

Event Description

Lower advia centaur xpt ca 19-9 results were obtained by the customer when reestablishing a baseline correlation study between the advia centaur xpt versus an alternate ca-19-9 test method (tosoh).The customer performed repeat testing with a second alternate method, and the results were higher compared to the advia centaur xpt results.There are no known reports that treatment was altered or prescribed or adverse health consequences due to the lower advia centaur xpt ca 19-9 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00230 on 12/15/2017 for lower advia centaur xpt ca 19-9 results when reestablishing a baseline correlation study with an alternate ca-19-9 test method.12/21/2017 - additional information: the patient samples were collected on (b)(6) 2017 and tested on (b)(6) 2017.12/21/2017 - correction: event date would be (b)(6) 2017.The customer observed correlation differences of results between the advia centaur xpt ca 19-9 assay compared to an alternate ca 19-9 test method (tosoh) previously used by the customer.The customer tested the patient samples on a second alternate ca 19-9 test method (beckman) which produced higher results compared to the advia centaur xpt ca 19-9 assay.There are no apparent issues with the customer's advia centaur xpt ca 19-9 assay calibrations.The patient samples are not available for further investigation.The instruction for use (ifu) under the warning section states the following: "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 instruction for use (ifu) under the intended use section states the following: "the advia centaur® ca 19-9 assay is an in vitro immunoassay for the quantitative measurement of the ca 19-9 tumor-associated antigen, in human serum, using the advia centaur, advia centaur xp, and advia centaur xpt systems.This assay is indicated for the serial measurement of ca 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas.The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum ca 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort.Ca 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined." the instrument is performing within specifications.No further evaluation of the device is required.There were other patient correlation runs performed where the advia centaur xpt results were lower (refer to mdr 1219913-2017-00231, mdr 1219913-2017-00232, mdr 1219913-2017-00233, and mdr 1219913-2017-00234).These mdrs are not affected by this additional information and correction.

• Brand Name: ADVIA CENTAUR XPT CA 19-9 ASSAY
• Type of Device: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 7123548
• MDR Text Key: 95828736
• Report Number: 1219913-2017-00230
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414574257
• UDI-Public: 00630414574257
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2018
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 052404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1