MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT CA19-9; CA19-9 IMMUNOASSAY

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.Siemens reviewed the information provided by the customer.It was noted that the 1:10 manual dilution generated a result of 11,898 u/ml.If this is true, then the value of the diluted sample before being corrected for the dilution factor would be 1189.8 u/ml.Since the top of the assay measuring range is 700 u/ml, it should not be possible to obtain a value of 1189.8 u/ml.Siemens has asked for confirmation of the dilution factor.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.".

Event Description

A customer observed discordant advia centaur xpt ca19-9 results with one patient sample upon dilution.The non-diluted result and the manually diluted result were above the assay measuring range, while the auto-diluted result was within the assay measuring range.None of the results were reported to the physician.The customer is waiting for a new sample draw from the patient for retesting.There is no indication that patient treatment was prescribed, delayed or altered.There was no report of adverse health consequences due to the discordant ca19-9 results.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr 1219913-2020-00296 on 09/24/2020.Additional information from 09/29/2020 through 10/07/2020: device was not serviced by a third party.The instrument was inspected prior to this event and after this event.The siemens customer service engineer cleaned the aspirate and reagent probes manually and performed precision run.The system did not demonstrate any abnormal fluctuations readings or quality control (qc) results.Siemens discussed dilution factors with the customer.The customer could not confirm whether the operator had entered an incorrect dilution factor or if the sample had been diluted incorrectly.Information regarding the expected testing on a new sample draw from the patient was not provided.The customer was not able to provide the patient's medical status or a list of medications/supplements the patient was taking.There is not enough volume of the initial sample to be sent to siemens for evaluation.Siemens reviewed the calibration and control data provided and there is no evidence of a problem.As stated in the dilution recovery section of the advia centaur xpt ca 19-9 instructions for use (ifu) (10629843 _en rev.H, 2019-11) "sample-dependent nonlinear dilutions can be observed." ; therefore, difference between the undiluted and autodiluted sample results can occur with some samples.Since the 1:100 autodiluted sample recovered 536 u/ml, the value before correction with the dilution factor would have been 5.36 u/ml, which is below the lowest sample listed in the precision section of the advia centaur xp/xpt ca 19-9 ifu.Therefore, imprecision at the low end of the assay range could be impacting the 1:100 autodiluted result.Given that a 1:10 manual dilution of a sample with dose of 11,898 u/ml would yield a result of 1,189.8 u/ml before being corrected by the dilution factor and the top of the assay range is 700 u/ml, the manual dilution result is not possible as described.The customer has not had similar issues with any other samples and their instrument is not having any performance issues.The cause of the nonlinear dilution results seen by the customer with this one sample when using advia centaur xpt ca 19-9 lot 463 could not be determined, but siemens cannot rule out pre-analytical factors or a sample issue.Siemens investigation is complete.Based on the investigation, no product problem was identified.The customer is operational.No further action is required.The result and conclusion codes have been updated to reflect the investigation results.Reference section h6 of this report for the updated codes.

• Brand Name: ADVIA CENTAUR XPT CA19-9
• Type of Device: CA19-9 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 10583973
• MDR Text Key: 209023608
• Report Number: 1219913-2020-00296
• 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
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2020
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 463
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR