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 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp ca19-9 results is unknown.The customer no longer has the ca19-9 diluent that was used to dilute the two samples.The customer also stated that the ca19-9 diluent is used for the manual 1:10 offline dilutions.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the limitations section: "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.Furthermore, patients known to be genetically negative for the lewis blood group antigens will be unable to produce the ca 19-9 antigen even in the presence of malignant tissue.Phenotyping for the presence of the lewis blood group antigen may be insufficient to detect true lewis antigen negative individuals.Even patients who are genotype positive for the lewis antigen may produce varying levels of ca 19-9 as the result of gene dosage effect.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.Warning: this device is not indicated for screening or the early detection of pancreatic cancer or as a diagnostic tool to confirm the presence or absence of malignant pancreatic disease.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.".

Event Description

Discordant advia centaur xp ca 19-9 results were obtained for samples from two patients when diluted.The difference in results was a ten fold increase.The initial results were reported.The result for patient 1 was questioned by the physician as the result was not expected for this patient.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the discordant ca 19-9 results.

Manufacturer Narrative

03/11/2016 additional information: the customer sent in the second draw from patient 2 for further testing and investigation.The patient sample was run neat and diluted with ca19-9 lot 374.Ca19-9 results (u/ml) neat result: >700; 1:200 dilution result: 92,127.There was not enough volume of the patient sample to be tested for interference.The cause for the discordant advia centaur xp ca19-9 results is unknown.The instrument is performing within specifications.No further evaluation of the device is 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.; 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: 5466408
• MDR Text Key: 39250201
• Report Number: 1219913-2016-00045
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

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 Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• 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