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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 02K91-23
Device Problem High Test Results (2457)
Patient Problem No Code Available (3191)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4); the patient had ct, gastroscopy, and colonoscopy procedures performed.
 
Event Description
The customer stated that the architect analyzer generated falsely elevated ca19-9 results on one patient compared to the roche method. The results provided were: on architect i1000
=
94. 8 / 115. 9 / 120 u/ml (reference range 0-37) / on i2000
=
123. 8 u/ml / roche e411
=
40. 04 (reference range 0-27). The patient has not been diagnosed with pancreatic cancer. Due to the architect ca19-9 results the patient had a ct, gastroscopy, and colonoscopy performed - all negative. It is unknown if the patient received iv contrast for the ct or gastroscopy. There was no impact to patient management reported. Per the adverse event categorization tool v7. 0, unnecessary invasive diagnostics (endoscopy and colonoscopy) with no adverse outcome is deemed an adverse event and is reportable.
 
Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling. There was no patient sample provided to assist in the investigation. Abbott reviewed the product for any trends, but the data did not identify any related to falsely elevated patient results. Historical performance of lot 50357m500 was evaluated using world wide data from abbott link. The patient data was analyzed and compared to an established control limit. This evaluation indicated that the patient median result for this lot is within the established control limits and no unusual reagent lot performance was identified. A review of the ca19-9 package insert and the architect operations manual shows adequate instructions for troubleshooting falsely elevated results is provided. Also, patient results were being compared to results obtained with another method which is not allowed per package labeling. Based on all available information and this investigation, the assay performed as intended and no product deficiency was identified. Additional information added to adverse event or product problem; relevant tests/laboratory data, including dates.
 
Manufacturer Narrative
The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended, and conclusions code was corrected in evaluation codes from (b)(4).
 
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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 Key6274696
MDR Text Key65672984
Report Number1415939-2017-00004
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodePL
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 04/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/12/2017
Device Catalogue Number02K91-23
Device Lot Number50357M500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
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: 01/24/2017 Patient Sequence Number: 1
Treatment
ARCHITECT I1000SR ANALYZER, LIST # 01L86-40,; SERIAL # (B)(4)
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