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

Catalog Number 02K91-38

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 2k91-38 that has a similar product distributed in the us, list number 2k91-29/2k91-33.(b)(6).

Event Description

The customer observed falsely depressed results while using architect ca 19-9xr reagents.The following data was provided for the same patient.Initial 24.46 u/ml, repeat 58.25 u/ml repeat at another facility using architect method, 48.92 u/ml the patient had not been previously tested for ca19-9 and the patient diagnosis was unknown.No impact to patient management was reported.Roche method was higher, 83.24 u/ml.The product package insert warns the user, the concentration of 1116-ns-19-9 reactive determinants obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity.Prior to changing assays, the laboratory must confirm baseline values for patients being serially monitored.

Manufacturer Narrative

An error was identified on jan 16, 2019.This report was filed against the incorrect manufacturing site.Manufacturer report 3002809144-2019-00023 has been submitted to correct this, and all follow up information will be provided in that report.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, field data review, device history review, instrument log review, and labeling review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.Log review did not identify any issues that contributed to the customer issue.Field data for lots in the field from october 1, 2017 and december 30, 2017 was reviewed.The patient data was analyzed by lot and compared to an established control limit.This evaluation indicated that the patient median result for the complaint lot was within the established control limits and no unusual reagent lot performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• 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: 7110389
• MDR Text Key: 95595063
• Report Number: 1415939-2017-00215
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052000
• 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,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2018
• Device Catalogue Number: 02K91-38
• Device Lot Number: 76024M800
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1