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

Catalog Number 02K91-38

Device Problem High Test Results (2457)

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.

Event Description

The customer observed falsely elevated ca19-9 results on the architect i2000 analyzer.The following data was provided sid (b)(4) : initial 178.53, repeat 15.78 u/ml.There was no impact to patient management reported.

Manufacturer Narrative

On (b)(6) 2016 the suspect medical device catalog number changed from 02k91-28 to 02k91-38.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing.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 and no unusual reagent lot performance was identified.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.

Manufacturer Narrative

The conclusion code was corrected to (b)(4).The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or 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: 6086937
• MDR Text Key: 59457304
• Report Number: 1415939-2016-00106
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/23/2017

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: 03/05/2017
• Device Catalogue Number: 02K91-38
• Device Lot Number: 62025M800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/17/2016; 04/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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
• Treatment: ARCHITECT I2000 ANALYZER; LN (B)(4) SN (B)(4)