MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CA 125 II; OC 125 DEFINED ANTIGEN

Catalog Number 02K45-28

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 3002809144-2016-00005 under a different manufacturing site.Upon retrospective review, it was discovered that the manufacturing site of (b)(4).As reported in mdr number 3002809144-2016-00005 was incorrect.This mdr is to correct the manufacturing site to (b)(4), u.S.A.(b)(4).Review of the ticket trending and lot search did not identify an increase complaint activity related to falsely elevated results.Accuracy testing was completed using retained kits of reagent lot 50278m500.Acceptance criteria were met, which indicates acceptable product performance.Labeling was reviewed and adequately addresses the issue under review.Additionally, during troubleshooting, the customer observed the reagent bottles, noting that the microparticle bottle had slimy particles that didn't dissolve.The architect ca 125 ii package insert states to visually inspect the bottle to ensure microparticles have been completely resuspended and not use if the microparticles do not resuspend.A deficiency was not identified as panel testing shows that the likely cause lot performed per specification.There is not enough information to reasonably suggest a malfunction as the falsely elevated results gave the expected results when tested with a different kit of the same reagent lot.This indicates a possible issue with the initial reagent kit (microparticles bottle issue).The architect cea assay is performing acceptably.

Event Description

The account generated false elevated architect ca125 ii results on 4 patient samples that repeated in normal range after replacing the reagent.Patient 1 (female, (b)(6)) tested architect ca125 ii of 52.2, 46.7, 37.2 but repeated 13.7 after replacement reagent (no unit of measurement provided).Patient 2 (female, (b)(6)) tested architect ca125 ii of 39.9, 49.8, 51.1 but repeated 14 after replacement reagent.Patient 3 (female, (b)(6)) tested architect ca125 ii of 30.8 but repeated 7 after replacement reagent.Patient 4 (female, (b)(6)) tested architect ca125 ii of 51.5 but repeated 8.9 after replacement reagent.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended at the customer site.However, no systemic issue and/or product deficiency was identified.The conclusion code in evaluation codes was changed from (b)(4).

• Brand Name: ARCHITECT CA 125 II
• Type of Device: OC 125 DEFINED ANTIGEN
• 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: 5664087
• MDR Text Key: 45600756
• Report Number: 1415939-2016-00056
• Device Sequence Number: 1
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K042731
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2016
• Device Catalogue Number: 02K45-28
• Device Lot Number: 50278M500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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