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Catalog Number 02K91-23
Device Problem High Test Results (2457)
Patient Problem No Code Available (3191)
Event Date 07/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This issue was previously reported under mdr number 3002809144-2017-00118 under the same suspect medical device but an incorrect manufacturer name, city and state. No customer returns were available. Investigation of the customer issue included a review of the complaint text, a search for similar complaints and a review of labeling. Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue. Complaint searches determined that there is normal complaint activity for architect ca 19-9xr reagent lot 67005m800. Historical performance of the reagent lot 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 which indicates that the lot is performing acceptably and comparable to other lots in the field. Labeling was reviewed and found to be adequate. Off label use was identified as the patient was not being monitored for pancreatic cancer. Based on the available information, no product deficiency of architect ca 19-9xr reagent lot 67005m800 was identified.
Event Description
The customer stated that erroneous architect ca 19-9xr results of 614. 30 and 856. 39 u/ml were generated for a patient (same sample) on (b)(6) 2017. A different sample from the same patient was tested on (b)(6) 2017 and the results were 729. 99 and 708. 62 u/ml. The physician disagreed with the result of 856. 39 u/ml. Additional patient information was later provided. The patient was redrawn on (b)(6) 2017. The architect ca 19-9xr result was 42 u/ml (retest 46. 42 u/ml). The patient is (b)(6) year old male being monitored yearly following diagnosis of colon cancer 20 years ago. The patient underwent gastroscopy and colonoscopy based on the elevated architect ca 19-9xr values. The results showed normal findings including bile ducts and pancreas. The lower ca 19-9xr results of 42 and 46. 42 u/ml more closely matched the patient's clinical history of low values. The patient is in good condition. No patient injury was reported due to the procedures performed.
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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 Key6897704
MDR Text Key89465097
Report Number1415939-2017-00183
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 Other Health Care Professional
Type of Report Initial
Report Date 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/08/2017
Device Catalogue Number02K91-23
Device Lot Number67005M800
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 Received09/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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: 09/27/2017 Patient Sequence Number: 1