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 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the elevated advia centaur xp ca 19-9 results with reagent lot 388 is unknown.The customer's quality control results were all acceptable at the time of the event.Siemens continues to investigate.The limitations section of the instructions for use (ifu) states: "warning" "do not use the advia centaur ca 19-9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of advia centaur ca 19-9.Normal levels of advia centaur ca 19-9 do not always preclude the presence of disease." "note" "do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".

Event Description

Customer performed a lot comparison between advia centaur xp ca 19-9 lot 48670388 (lot 388) and lot 386 and observed that qc and patient results were higher with reagent lot 48670388.There are no reports that treatment was altered or prescribed or adverse health consequences due to the higher results with advia centaur xp ca 19-9 reagent lot 48670388.

Manufacturer Narrative

Mdr 1219913-2016-00191 was filed on october 24, 2016 reporting a high bias with advia centaur xp ca 19-9 reagent lot 48670388 compare to reagent lot 386.January 12, 2017 - evaluation result: siemens performed a study comparing advia centaur xp ca 19-9 reagent lots 386 and 388 with bio-rad control lots 23910, 23920 and 54610 and 10 patient pools.The customers survey samples and patient samples were run on different lots on different days.When the customer ran master curve materials (mcm) with a different readypack of lot 388 than was used to test the survey samples and patient samples the mcms recovered in range.The customer reset their control ranges.The root cause of the bias the customer saw with survey samples and patient samples cannot be determined but may have been due to some sort of handling issue with samples or a shipping/handling issue with the customer's lot 388 reagents.Based on the available information centaur ca 19-9 lot 388 is performing as intended.Advia centaur xp ca 19-9 results in u/ml sample reagent lot 386 reagent lot 388 control lot 23911 15.3 17.4 control lot 23912 72.0 65.5 control lot 23913 223 195 control lot 23921 16.1 16.3 control lot 23922 76.1 70.9 control lot 23923 202 184 control lot 54611 29.3 30.1 control lot 54612 75.8 66.3 control lot 54613 175 148 pool 1 50.9 53.5 pool1-2 52.9 56.3 25-30 34.0 38.8 2-45 53.9 57.0 100 145 141 >450 528 466 >450-2 504 476 500 523 475 1-20 24.1 27.1 300 439 374 no further investigation required.

• 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.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 6050424
• MDR Text Key: 58196233
• Report Number: 1219913-2016-00191
• 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: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

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: 05/14/2017
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 48670388
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1