MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CA 19-9XR

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.

• 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 Key: 7098612
• MDR Text Key: 95822459
• Report Number: 1415939-2017-00214
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• 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 Date: 02/23/2018
• Device Catalogue Number: 02K91-39
• Device Lot Number: 74005M800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1