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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 02K91-24
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer stated that falsely decreased architect ca 19-9xr results of 790 and 850 u/ml (autodiluted 1:10) were generated for a patient being monitored for pancreatic cancer. The sample tested at 1848 u/ml (manually diluted 1:10) which was the expected result. 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
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key8138597
MDR Text Key130330565
Report Number3002809144-2018-00538
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K052000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/15/2018
Device Catalogue Number02K91-24
Device Lot Number79030M800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
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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