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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 02K91-39
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Note: the same patient was reported in manufacturers report number 1415939-2017-00213 for the additional likely cause lot number and analyzer serial number.This report is being filed on an international product, architect ca19-9 list 02k91-39 that has a similar product distributed in the us, list number 02k91-29 and 02k91-33 which is manufactured in (b)(4).
 
Event Description
The customer observed falsely elevated ca19-9 result on the architect i2000sr analyzer.The following data was provided for these patients with an unknown diagnosis (u/ml): specimen 1 initial test: 688.18 retest: 1144.6 on (b)(4) retest 2: 1092 retest 3: 961 on (b)(4).Specimen 2 initial test: 495 retest: 857 on (b)(4) retest 2: 750 retest 3: 776 on (b)(4).Specimen 3 initial test: 501 retest: 946 on (b)(4) retest 2: 644 retest 3: 686 on (b)(4).Specimen 4 initial test: 148 retest: 12.5 on (b)(4) retest 2: 9.92 retest 3: 12.6 on (b)(4).There was no impact to patient management reported.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
 
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Brand Name
ARCHITECT CA 19-9XR
Type of Device
CA 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 Key7098612
MDR Text Key95822459
Report Number1415939-2017-00214
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/23/2018
Device Catalogue Number02K91-39
Device Lot Number74005M800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2017
Initial Date FDA Received12/07/2017
Supplement Dates Manufacturer Received12/19/2017
Supplement Dates FDA Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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