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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 02K91-28
Device Problem High Test Results (2457)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Initial reporter additional local phone number is (b)(6).
 
Event Description
The customer observed falsely elevated ca19-9 results generated with architect ca-19-9xr reagents. The following data was provided (u/ml). Sid (b)(6) initial 495. Roche method using another sample showed lower result, 7. Siemens centaur method was lower, 5, 7. The initial sample was retested using another unknown method, 6, however the specific methods used for this result was not provided. Due to the initially high result, a colonscopy was performed and was negative. The patient had been diagnosed with stipsis, constipation, and weight loss. The patient was not being monitored for pancreatic cancer.
 
Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and review of field data. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The architect ca19-9 package insert includes the intended use of this assay is an aid in the management of pancreatic cancer patients. Information provided by the customer indicated that patient did not have pancreatic cancer, and the assay was being used outside the intended use. Review of field data for reagent (b)(4) did not identify unusual reagent lot performance. 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. Conclusion code was corrected.
 
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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 Key6085978
MDR Text Key59571364
Report Number1415939-2016-00105
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeIT
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 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/13/2017
Device Catalogue Number02K91-28
Device Lot Number50379M500
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 Manufactured03/01/2016
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: 11/08/2016 Patient Sequence Number: 1
Treatment
ARCHITECT I2000SR ANALYZER; LIST NUMBER 03M74-02; SERIAL NUMBER (B)(4)
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