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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT CA19-9 CA19-9 IMMUNOASSAY Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2020
Event Type  malfunction  
Manufacturer Narrative
Siemens healthcare diagnostics is investigating. The full context of the scenario above is unknown (e. G. Rationale for testing on 3 platforms, which results would be considered accurate, whether patients were re-baselined prior to implementation of a new tumor marker assay, etc). It is well known for tumor markers that results from different platforms/assays cannot be used interchangeably and this limitation is expressly stated in siemens ifus for tumor marker assays. The instructions for use states: "warning: the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values. The advia centaur ca 19-9 assay is based on the 1116-ns-19-9 antibody available through agreement with fujirebio diagnostics, inc. Assays using antibodies other than 1116-ns-19-9 may give different results. " "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " siemens has requested additional information mdr 1219913-2020-00104 was filed for samples with collection date (b)(6) 2020. Mdr 1219913-2020-00105 was filed for samples with collection date (b)(6) 2020. Mdr 1219913-2020-00107 was filed for samples with collection date (b)(6) 2020. Mdr 1219913-2020-00108 was filed for samples with collection date (b)(6) 2020.
 
Event Description
A customer is questioning advia centaur xpt ca19-9 results for multiple patient samples tested with one reagent lot. This customer transitioned from immulite to the advia centaur xpt ca19-9 method. A patient correlation study was performed at the customer site during the transition; customer observed acceptable correlation results. The customer then observed discordant low advia centaur xpt ca19-9 results when they began reporting patient results. The customer provided atellica im ca19-9 results for troubleshooting. The customer is not questioning the atellica im ca19-9 results. 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.
 
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Brand NameADVIA CENTAUR XPT CA19-9
Type of DeviceCA19-9 IMMUNOASSAY
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown, ny
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
east walpole, ma
Manufacturer Contact
stacy loukos
333 coney street
east walpole, ma 
6608576
MDR Report Key9950940
MDR Text Key203691858
Report Number1219913-2020-00106
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K031393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/12/2020
Device Model NumberN/A
Device Catalogue Number10491244
Device Lot Number457
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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