MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT 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 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating the cause of the discordant ca19-9 results.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.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: do not use the advia centaur cp ca 19-9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of advia centaur cp ca 19-9.Normal levels of advia centaur cp ca 19-9 do not always preclude the presence of disease.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 assay specific values to evaluate quality control results." mdr 1219913-2019-00240 (initial result), mdr 1219913-2019-00249 (advia centaur xp result), mdr 1219913-2019-00250 (atellica im initial result) and mdr 1219913-2019-00251 (atellica im repeat result) were filed for the same event.

Event Description

A discordant high advia centaur xpt ca 19-9 result was obtained for a patient sample.The patient sample was repeated, and the result was high.The high results were reported to the physician and questioned.The patient sample was also run on the advia centaur xp and atellica im platforms.The results were high.The patient sample was tested on an alternate method and the results were lower.A corrected report was issued.An endoscopy was performed.The results of the endoscopy were not provided.Other clinical diagnostic tests performed, and the result was nonspecific gastritis.There was no report of adverse health consequences due to the discordant ca 19-9 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00241 on november 20, 2019.On 11/26/2019 additional information: the sid (b)(6) is the first blood sample and sid (b)(6) is the second one.Both sids are from the same patient.The results of the endoscopy is colitis.The patient was tested on the advia centaur xpt for the following: afp: <1.3 ng/ml cea: 78.57 ng/ml hbsii: 0.27 index ca125: 25.1 u/ml hcv: 0.19 index ehiv: 0.12 index siemens healthcare diagnostics continues to investigate.Mdr 1219913-2019-00240 supplemental report 1, mdr 1219913-2019-00249 supplemental report 1, mdr 1219913-2019-00250 supplemental report 1, and mdr 1219913-2019-00251 supplementla report 1 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00241 on november 20, 2019.Siemens filed the mdr 1219913-2019-00241 supplemental report 1 on december 19, 2019.01/08/2020 additional information: the country does not import hbt tube (heterophilic blocking tube) yet for further testing.01/10/2020 additional information: the initial issue was reported as advia centaur xpt ca19-9 patient's results were abnormally high.Siemens cannot definitively determine the cause of this discrepant 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 the advia centaur ca19-9).Siemens received response from region that the sample was discarded, and no further testing can be conducted.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00240 supplemental report 2, mdr 1219913-2019-00249 supplemental report 2, mdr 1219913-2019-00250 supplemental report 2, and mdr 1219913-2019-00251 supplemental report 2 were filed for the same event.

• Brand Name: ADVIA CENTAUR XPT 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: 9347274
• MDR Text Key: 219792654
• Report Number: 1219913-2019-00241
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414574257
• UDI-Public: 00630414574257
• 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,Followup
• Report Date: 01/15/2020

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: 05/02/2020
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 24051452
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 11/26/2019; 01/08/2020
• Supplement Dates FDA Received: 12/19/2019; 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR