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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 02K91-39
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2019
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 2k91-32 that has a similar product distributed in the us, list number 2k91-33.
 
Event Description
The customer questioned decreasing architect ca 19-9xr results for a patient being monitored monthly for pancreatic cancer. The patient has no history of chemotherapy treatment. On (b)(6) 2019: 203. 3 u/ml; on (b)(6) 2019: 585. 11 u/ml; on (b)(6) 2019: 41. 6 u/ml; on (b)(6) 2019: 36. 4 u/ml. No adverse 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
christian lee
100 abbott park road
dept 09b9, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key8871386
MDR Text Key154121920
Report Number3002809144-2019-00490
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeJA
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 09/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/05/2019
Device Catalogue Number02K91-39
Device Lot Number96023M800
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 Received09/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2019
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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