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

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.Siemens reviewed internal assay information comparing advia centaur xp ca19-9 to atellica im ca19-9.There is no siemens internal data available comparing samples with high titer ca 19-9 similar to customer's samples.Siemens is attempting to procure high titer ca 19-9 samples for further investigation.However, siemens internal data showed a high titer sample diluted onboard an advia centaur that recovered similarly to a manual dilution which is not like what the difference the customer saw.This indicates the dilution issues are not common to all samples.Siemens continues to investigate.The instructions for use states in the interpretation of results section, "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." mdr 1219913-2020-00161 was filed for results obtained on (b)(6) 2020.Mdr 1219913-2020-00163 was filed for results obtained on (b)(6) 2020.Mdr 1219913-2020-00164 was filed for results obtained on (b)(6) 2020.

Event Description

A customer tested two high titer ca 19-9 samples taken from the same patient and observed that results of the on-board and manually diluted samples were discordant low with advia centaur xp ca19-9 as compared to the diluted results from an alternate testing method (atellica im ca 19-9).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 filed initial mdr on july 10, 2020.Additional information 07/27/2020: the customer had two high titer ca 19-9 patient samples from the same patient that recovered lower (~41 - 50%) when 1:100 autodilutions (onboard) were tested with advia centaur xp ca 19-9 lot: 459 vs the atellica im ca 19-9 lots: 462 and 464.The customer also manually diluted the samples 1:100 and 1:200, and the 1:100 autodilutions with the advia centaur xp ca 19-9 lot: 459 recovered lower (~21 - 31%) than manual dilutions.The customer used diluent lots: 3310 (advia centaur xp) and 3300 (atellica im) which are from the same bulk diluent lot so diluent lot is not causing the issue.There was not enough sample to be sent to siemens for evaluation.Siemens investigation team sourced (10) ca 19-9 patient samples with concentrations from 5,000 - 35,000 u/ml and performed 1:100 autodilutions (onboard) using advia centaur xp ca 19-9 lot: 459 and the atellica im ca 19-9 lot: 464.Advia centaur xp ca 19-9 1:100 autodilutions with lot: 459 recovered on average 6% higher than atellica im ca 19-9 1:100 autodilutions with lot: 464.Nine of the samples also had enough volume to a perform 1:100 manual dilutions.Advia centaur xp ca 19-9 1:100 autodilutions with lot: 459 recovered on average -7% lower than advia centaur xp ca 19-9 1:100 manual dilutions with lot: 459.Siemens was not able to duplicate the biases the customer observed with their samples from the one patient.The biases from siemens' study are acceptable performance for the advia centaur xp ca 19-9 assay.As noted in the dilution recovery section of the advia centaur xp/xpt ca 19-9 instructions for use (ifu) (10629843_en rev.H, 2019-11), "sample-dependent nonlinear dilutions can be observed".The cause of the dilution recovery bias seen by the customer with samples from one patient when using when using advia centaur xp ca 19-9 lot: 459 and atellica im ca 19-9 lot: 464 could not be determined but siemens cannot rule out a sample issue or normal assay performance.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.Mdr 1219913-2020-00161 supplemental report 1 was filed for results obtained on 06/10/2020.Mdr 1219913-2020-00163 supplemental report 1 was filed for results obtained on 06/12/2020.Mdr 1219913-2020-00164 supplemental report 1 was filed for results obtained on 06/17/2020.

• Brand Name: ADVIA CENTAUR XP CA19-9
• Type of Device: CA19-9 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10258655
• MDR Text Key: 219000974
• Report Number: 1219913-2020-00162
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2020
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 459
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1