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

Catalog Number 02K45-23

Device Problem High Test Results (2457)

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

Event Date 03/13/2015

Event Type  malfunction  

Event Description

The customer observed a falsely elevated ca125 result on the architect i2000sr analyzer.The following data was provided: sid (b)(6) initial 232.4, repeat 11.4 u/ml which matched clinical picture.There was no impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.(b)(4).An evaluation is in process.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and accuracy testing.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.Accuracy testing, using a retained kit and three levels of an internal panel with known concentrations, met all specifications.Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.

• 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 350
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• 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: 4662513
• MDR Text Key: 20375227
• Report Number: 1415939-2015-00006
• Device Sequence Number: 1
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2015
• Device Catalogue Number: 02K45-23
• Device Lot Number: 42527M500
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(4)