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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT CA 19-9XR

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ABBOTT GERMANY ARCHITECT CA 19-9XR Back to Search Results
Catalog Number 02K91-32
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product, architect ca 19-9xr, list 2k91-32, that has a similar product distributed in the us, list number 2k91-33. Patient information: no further information was obtained. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported a falsely depressed architect ca 19-9xr result for a (b)(6) female pancreatic cancer patient. Sample id (b)(6) generated 18. 43 with repeat of 15. 09 u/l. The sample was tested on architect at an alternate facility generating 34. 79 u/ml. The customer indicated the result was discrepant with the (b)(6) 2019 architect result of 280 u/ml. The sample was further tested on the immulite (332. 1 u/ml) and cobas (218. 2 u/ml) generating similar result to the (b)(6) result. No impact to patient management was reported.
 
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Brand NameARCHITECT CA 19-9XR
Type of DeviceCA 19-9
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key8528694
MDR Text Key142482677
Report Number3002809144-2019-00209
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeSR
PMA/PMN Number
K052000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/13/2019
Device Catalogue Number02K91-32
Device Lot Number93018M800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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