MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CA 15-3 ASSAY; CA 15-3 IMMUNOASSAY

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2014

Event Type  malfunction  

Event Description

Discordant advia centaur ca 15-3 results were obtained for four samples from different patients during a correlation study.A high bias was observed when performing patient correlation between ca15-3 lot 155 and lot 156.The patient samples were run on a second advia centaur and the results were similar.The quality control (qc) was also showing a high bias for lot 156.The level 3 control was out of range for the customer's qc range.The qc was repeated with a new calibrator lot and the values were in range.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the discordant ca 15-3 results.

Manufacturer Narrative

The cause for the discordant advia centaur ca15-3 results is unknown.The customer received ca 15-3 lot 157.The customer ran the qc with lot 157 and the values were within peer ranges.The patient correlation was performed with lot 156 and 157.The results were acceptable (no data was provided).The customer did not have any material left from lot 155 and could not run a comparison with lot 157.The customer believes that lot 155 may have been running lower since lot 156 and 157 are correlating.A reveiw of biorad unity data for the lot 19970 controls supports that the advia centaur ca15-3 lot 155 was running low at the customer's site.Lot 155 lot 156 level unity mean bias mean bias 1997 122.6 16.4 -27% 22.6 0% 19972 61.4 51.1 -17% 65.0 6% 19973 113 88.0 -22% 118 5% siemens healthcare diagnostics is investigating.The ifu under the limitation section states the following: "note: do not interpret levels of ca 15-3 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 15-3 within the range observed in healthy individuals.Additionally, elevated levels of ca 15-3 can be observed in patients with nonmalignant diseases.Measurements of ca 15-3 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.Warning: do not use the advia centaur ca 15-3 assay as a screening test or for diagnosis.Normal levels of ca 15-3 do not always preclude the presence of disease.".

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2014-00301 on december 19, 2014.On 01/26/2014 additional information: siemens has compared the advia centaur ca15-3 lot 155 and lot 156 recovery with bio-rad control lots 19950 and 19970 as well as patient samples.Siemens did not observe a difference of more than 8% between lots with either controls or patient samples.The average bias was -1%.(b)(6).Siemens was not able to confirm the bias the customer observed between the advia centaur ca15-3 lots 155 and lot 156.The cause for the discordant advia centaur ca15-3 results is unknown.The instrument is performing within specifications.No further evaluation fo the device is required.The 02/06/2015 correction: typographical correction in the initial report for the biorad unity data for lot 155, qc level 19971.Lot 155.Level: 19971, unity: 22.6, mean: 16.4, bias: -27%.

• Brand Name: ADVIA CENTAUR CA 15-3 ASSAY
• Type of Device: CA 15-3 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• 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: 4345719
• MDR Text Key: 14879905
• Report Number: 1219913-2014-00301
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/29/2014

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: 04/08/2015
• Device Model Number: N/A
• Device Catalogue Number: 00128609
• Device Lot Number: 156
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2015
• 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