MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP 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 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp ca19-9 results is possibly due to the differences in assay methods.The ifu states in the warning before the intended use section: "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 (b)(4) assays using antibodies other than 1116-ns-19-9 may give different results.Both the advia centaur xp ca 19-9 results and the alternate laboratory results are clearly elevated indicating the presence of malignant disease.Based on the available information, the advia centaur xp ca 19-9 assay is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.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 Description

Discordant advia centaur xp ca 19-9 results with an alternate laboratory were obtained for samples from two patients.The results were questioned by the oncologist.The difference in results was greater than 30%.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca 19-9 results.

• Brand Name: ADVIA CENTAUR XP 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; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 6521987
• MDR Text Key: 74041511
• Report Number: 1219913-2017-00103
• Device Sequence Number: 1
• Product Code: NIG
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2017

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: 09/16/2017
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 08738394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1