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Catalog Number 02K91-38
Device Problem High Test Results (2457)
Patient Problem Misdiagnosis (2159)
Event Date 01/11/2017
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 02k91-38, that has a similar product distributed in the us, list number 02k91-27.
Event Description
The customer reports falsely elevated architect ca 19-9 xr assay results for one patient (sid (b)(6)). The following information was provided: on (b)(6) 2017 the patient generated an architect ca 19-9 assay result of 163. 58 u/ml. The same sample generated a result of 17 u/ml on the roche platform (contrary to the architect ca 19-9 xr assay package insert, which warns the customer that different manufacturer' methods cannot be used interchangeably). The customer reports that this type of scenario has been repeated over time and provided the following results: on (b)(6) 2015: architect ca 19-9 xr
53. 7 u/ml, cea
1. 14 ng/ml, ca 125
10. 3 u/ml and ca 15-3
9. 5 u/ml. On (b)(6) 2015: architect ca 19-9 xr
109. 3 u/ml with ortho ca 19-9 result of 9 u/ml (the lab noted on their report that the architect ca 19-9 xr is not to be used as a screening assay), cea
1. 14 ng/ml, afp
2. 0 ng/ml. On (b)(6) 2016: architect ca 19-9 xr
157. 38 u/ml, cea
1. 28 ng/ml, ca 125
12. 1 u/ml and ca 15-3
6 u/ml. On (b)(6) 2016: architect ca 19-9 xr
262. 6 u/ml, cea
1. 16 ng/ml, afp
1. 79 ng/ml, ca 125
14. 20 u/ml and ca 15-3
6. 40 u/ml. On (b)(6) 2016
architect ca 19-9 xr
187. 62 u/ml and afp
2. 09 ng/ml. Over this period of time (no specific dates provided by the customer), the patient underwent two colonoscopies and two gastroscopies with no evidence of disease found. No adverse impact to the patient's health was realized as a result of these procedures.
Manufacturer Narrative
A review of complaint tracking and trending metrics was performed and identified no related adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation. No non-conformances or deviations were identified. A sample from the patient in question was returned for analytical specificity testing for this evaluation. The sample was treated with a heterophilic blocking tube (hbt) along with manual dilutions. All dilution results were outside the evaluation criteria indicating the presence of an interferent. The hbt treatment produced results which were not equivalent to the neat sample, indicating interference due to heterophilic antibodies. The architect ca 19-9xr assay package insert and the architect system operations manual contain information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred. Based on the information obtained through this evaluation, the device met performance specifications and performed as intended at the customer site. Use error caused the issue as the returned patient sample identified the presence of heterophilic antibodies, which per the product labeling, can cause falsely elevated results. No systemic issue or product deficiency was identified.
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Type of DeviceCA 19-9,
Manufacturer (Section D)
100 abbott park road
abbott park IL 60064 3500
Manufacturer (Section G)
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
MDR Report Key6283969
MDR Text Key66011049
Report Number1415939-2017-00006
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/16/2017
Device Catalogue Number02K91-38
Device Lot Number64023M800
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 Received04/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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: 01/27/2017 Patient Sequence Number: 1