MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 19-9; IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

All bio-rad controls with ca 19.9 were within the normal ranges.Siemens healthcare diagnostics is investigating the cause of the discordant ca19-9 results.The ifu states in the limitations section: "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.The concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Ca 19-9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Therefore, it is important to use assayspecific values to evaluate quality control results." mdr 1219913-2019-00275 (initial result) was filed for the same event.

Event Description

An advia centaur xp ca 19-9 greater than 700 u/ml (positive) result was obtained for a patient sample.The patient sample was diluted and repeated.The result was positive.The positive results were reported to the physician and questioned.The patient sample was tested on an alternate method and the result was negative.A corrected report was issued.The negative result was in agreement with the clinical picture of the patient.There is no indication of a cancer diagnosis with this patient.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca 19-9 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00276 on december 19, 2019.01/09/2020 additional information: the initial issue was reported as advia centaur xp ca19-9 patient's results were abnormally high with lot 445.Siemens cannot definitively determine the cause of this discordant result.Contributing factors such as sample integrity or preanalytical variables cannot be ruled out.Quality control was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.There is a possibility that this represents a heterophilic (hama) interference which we know can occur in any immunoassay despite the presence of blocker substances (mouse serum and bgg in centaur ca19-9).Siemens received response from region the hbt cannot be provided in china, and no further testing can be conducted.The assay meets specification.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00275 supplemental report 1 was filed for the same event.

• Brand Name: ADVIA CENTAUR XP CA 19-9
• Type of Device: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9482610
• MDR Text Key: 219509162
• Report Number: 1219913-2019-00276
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414574028
• UDI-Public: 00630414574028
• Combination Product (y/n): N
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 63418445
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR