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U.S. Department of Health and Human Services

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

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ABBOTT LABORATORIES ARCHITECT CA 19-9XR Back to Search Results
Catalog Number 02K91-38
Device Problem High Test Results (2457)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 02k91-38 that has a similar product distributed in the us, list number 2k91-27.
 
Event Description
The customer observed falsely elevated ca 19-9 results generated using the architect ca 19-9xr reagents. The following data was provided (u/ml). Initial (no sid) 113. 89. Repeat with a different sample ((b)(6)) less than 0. 2 in duplicate. Repeat (no sid) repeat 137. 99, 135. Roche method showed negative results, 29. 59. The patient received a gastroscopy (upper gastro intestinal endoscopy) that found no abnormalities. The patient gastrointestinal tract was normal during a physical examination. The patient was not being monitored for pancreatic cancer.
 
Manufacturer Narrative
(b)(4), no code available, unnecessary endoscopy. Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and accuracy testing. No adverse trend was identified for the customer issue. Labeling was reviewed and found to be adequate. Returns were not available. Clinical accuracy testing was performed using an internal panel and in-house retained kits of the likely cause reagent lot stored at the recommended storage condition. Accuracy testing met all specifications. Based on all available information and abbott diagnostics complaint investigation, the assay performed as intended and no product deficiency was identified.
 
Manufacturer Narrative
The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended. However, no systematic issue or product deficiency was identified.
 
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Brand NameARCHITECT CA 19-9XR
Type of DeviceCA 19-9
Manufacturer (Section D)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064 3500
Manufacturer (Section G)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064 3500
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key5833232
MDR Text Key50745577
Report Number1415939-2016-00081
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K052000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date11/11/2016
Device Catalogue Number02K91-38
Device Lot Number50410M500
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 Received04/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/29/2016 Patient Sequence Number: 1
Treatment
SERIAL NUMBER (B)(4)
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