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 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the elevated advia centaur xp ca 19-9 results is unknown.Siemens has requested the sample for further investigation.The limitations section of the instructions for use (ifu) states the following: "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 observed elevated advia centaur xp ca 19-9 results on two samples from the same patient compared to results from an alternate laboratory.The elevated results did not agree with the clinical picture.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp ca 19-9 results.

Manufacturer Narrative

Mdr 1219913-2016-00226 was filed on (b)(6) 2016 listing the type of report (section g7) as a 5-day report.The report should have been filed as an initial report.

Manufacturer Narrative

Mdr 1219913-2016-00226 was filed on november 23, 2016 reporting elevated advia centaur xp ca 19-9 results on two samples from the same patient compared to results from an alternate laboratory.The elevated results did not agree with the clinical picture.A supplemental report was filed on november 23, 2016 with a correction to the report type.December 19, 2016 siemens requested the samples for additional investigation, however, the samples were not available.No additional investigation can be performed since the samples are not available.Based on the available information, this is a sample specific issue and the advia centaur xp ca 19-9 assay is performing as intended.Additionally, it was noted, the patient is being monitored for ovarian cancer.

• 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: 6124363
• MDR Text Key: 60787207
• Report Number: 1219913-2016-00226
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2017
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 33688386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR