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 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating and has requested that the sample be sent to siemens for testing.Quality control results were in range at the time of the elevated results.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the limitations section of the instructions for use states: 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 assay-specific values to evaluate quality control results." the following is a list of mdrs filed for this event: mdr 1219913-2019-00136 filed for the sample dated 12/20/2018.Mdr 1219913-2019-00137 filed for the sample dated 02/18/2019.Mdr 1219913-2019-00138 filed for the sample dated 04/11/2019.

Event Description

Customer observed elevated results with the advia centaur xp ca 19-9 assay compared to the clinical picture and two alternate methods on four patient samples from the same patient.There are no reports that treatment was altered or prescribed based on the elevated advia centaur xp ca 19-9 results.Mdr 1219913-2019-00136 is filed for the sample dated 12/20/2018.Mdr 1219913-2019-00137 is filed for the sample dated 02/18/2019.Mdr 1219913-2019-00138 is filed for the sample dated 04/11/2019.Mdr 1219913-2019-00139 is filed for the sample dated 06/20/2019.

Manufacturer Narrative

Siemens filed mdrs for a customer observation of elevated results with the advia centaur xp ca 19-9 assay compared to the clinical picture and two alternate methods on four patient samples from the same patient.Mdr (b)(4) is filed for the sample dated (b)(6)2018 mdr (b)(4) is filed for the sample dated (b)(6)2019 mdr (b)(4) is filed for the sample dated (b)(6)2019 mdr (b)(4) is filed for the sample dated (b)(6)2019 (b)(6)2019 - additional information siemens received the sample and performed the following analysis: sample was tested in duplicate neat and after treatment with a heterophilic blocking tube (hbt) with atellica ca 19-9 reagent lot 052447.The mean results were 224.7 u/ml for the neat result and 208.5 u/ml for the hbt treated sample.The hbt treatment caused a 7% lowering of the result.Although root cause could not be definitively identified, an extremely high titer of heterophilic interference may likely be the cause of the 7% effectiveness in lowering the ca 19-9 result.Per the scantibodies laboratory instructions for use limitations statement "there may be some samples with extremely strong heterophilic interference.In such cases the hbt may not be able to block all of the assay interference." per the advia centaur ca 19-9 instructions for use limitations statement: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." this is not a product issue and no further investigation is required.Mdr (b)(4) and mdr (b)(4) supplemental 1 were filed for the sample dated (b)(6)2018 mdr (b)(4) and mdr (b)(4) supplemental 1 were filed for the sample dated (b)(6)2019 mdr (b)(4) and mdr (b)(4) supplemental 1 were filed for the sample dated (b)(6)2019 mdr (b)(4) and mdr (b)(4) supplemental 1 were filed for the sample dated (b)(6)2019.

• 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
• MDR Report Key: 8855691
• MDR Text Key: 200285582
• Report Number: 1219913-2019-00139
• 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: 10/07/2019

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: 12/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 445
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR