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 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the ca (b)(4) discordant results is unknown.The reagent readypack number (b)(4) was questioned.The calibration and quality controls were not performed with readypack number (b)(4).The solid phase was completely mixed well and there were no clumps.The quality control was run and the values were in range for the other reagent readypack.Siemens healthcare diagnostics is investigating.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." the ifu states in the limitations section: "warning do not use the advia centaur ca (b)(4) assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of advia centaur ca (b)(4).Normal levels of advia centaur ca (b)(4) do not always preclude the presence of disease.Note do not interpret serum levels of ca (b)(4) as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca (b)(4) within the range observed in healthy individuals.Additionally, elevated levels of ca (b)(4) can be observed in patients with nonmalignant diseases.Measurements of ca (b)(4) should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".

Event Description

Discordant advia centaur xp ca (b)(4) results were obtained for samples from six patients between two reagent readypacks from the same lot number.The patient samples were tested on reagent readypack number (b)(4) and the results were high.The patient samples were repeated on another reagent readypack (number not provided) and the results were negative.The negative results were reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca (b)(4) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00173 on september 23, 2016.On 09/26/2016 correction and additional information: clarification was received as to the number of patients tested.The initial mdr states the samples were six patients.The actual number of patients is five.For the data included in the initial mdr, patient 2 and patient 3 are the same patient.The actual patient data is as follows: ca 19-9 results (u/ml): patient 1: female, (b)(6).Initial result: 240.8 u/ml.Repeat result: 21.14 u/ml.Patient 2: female, (b)(6).Initial result: 215.21 u/ml.Repeat result: 17.08 u/ml.Patient 3: male, (b)(6).Initial result: 205.35 u/ml.Repeat result: 9.37 u/ml.Patient 4: male, (b)(6).Initial result: 213.25 u/ml.Repeat result: 13.11 u/ml.Patient 5: female, (b)(6).Initial result: 210.99 u/ml.Repeat result: 8.7 u/ml.Patient 1 to patient 4: physical examination.Patient 5: stomach ache.(b)(4).Siemens healthcare diagnostics has investigated.The issue appears to be isolated to one reagent readypack.The customer indicated there were no clumps in the solid phase.The cause could not be determined since the readypack is not available for investigation.The readypack that generated the elevated results was most likely exposed to some kind of shipping/handling event that compromised it.The cause for the ca19-9 discordant results is unknown.Improper reagent handling is suspected to have caused this issue.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: 5975197
• MDR Text Key: 55569144
• Report Number: 1219913-2016-00173
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2017
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 052384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• 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