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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 High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This event is being filed on an international product, architect ca19-9, list 02k91-32, that has a similar product distributed in the us, list numbers 2k91-29 and 2k91-33.
 
Event Description
The customer observed a falsely elevated architect ca19-9xr patient result.Previous results have been 12.0 ((b)(6) 2017), 12.1 ((b)(6) 2017), 293.6 and 242.3 ((b)(6) 2018), 504.3 ((b)(6) 2018), 14.2 ((b)(6) 2018), and 10.4 ((b)(6) 2018).Cea had also been tested in (b)(6) 2018 (2.1) and (b)(6) 2018 (1.9).No impact to patient management was reported.
 
Manufacturer Narrative
An investigation was performed by reviewing the complaint text, service history, tracking and trending metrics, and the current labeling for the architect ca-19-9xr package insert.A review of the product labeling concluded that the issue is sufficiently addressed.No trend associated with the architect ca 19-9xr discrepant results.No product deficiency was identified.
 
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Brand Name
ARCHITECT CA 19-9XR
Type of Device
CA 19-9
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8116769
MDR Text Key129681436
Report Number3002809144-2018-00529
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
PMA/PMN Number
K052000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/16/2019
Device Catalogue Number02K91-32
Device Lot Number87013M800
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR, LIST 03M74-01; ARCHITECT I2000SR, LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4)
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