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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA19-9 CA19-9 IMMUNOASSAY Back to Search Results
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.
 
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Brand NameADVIA CENTAUR XP 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 Key10258655
MDR Text Key219000974
Report Number1219913-2020-00162
Device Sequence Number1
Product Code NIG
UDI-Device Identifier00630414574028
UDI-Public00630414574028
Combination Product (y/n)N
Reporter Country CodeSN
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 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/25/2020
Device Model NumberN/A
Device Catalogue Number10491244
Device Lot Number459
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 Received07/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2019
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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