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

Catalog Number 02K45-25

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

The customer stated that an architect ca 125 ii result of 19 u/ml was generated for a patient that previously tested at 60 u/ml.The sample retested at 61.6, 59.8 and 58.3 u/ml.No adverse impact to patient management was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Review of historical complaint trending and lot search data for architect ca 125 ii reagent lot 41540m500 did not identify an increase in complaint activity for the issue under investigation.Accuracy testing was completed using retained kits of reagent lot 41540m500.Acceptance criteria was met, which indicates acceptable product performance.A deficiency was not identified as panel testing shows that the likely cause lot performs per specification.No malfunction was identified since the issue involves a discreet sample.Per the complaint text, the sample was re-centrifuged and retests on two different instruments produced the expected results.Additionally, the specimen collection and preparation for analysis section of the architect ca 125 ii package insert provides conditions that may have contributed to the erroneous result.

• 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: 4747957
• MDR Text Key: 18039237
• Report Number: 1415939-2015-00011
• Device Sequence Number: 1
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042731
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2015
• Device Catalogue Number: 02K45-25
• Device Lot Number: 41540M500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• 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: LIST 08C89-01, SERIAL: (B)(4); ARCHITECT I2000 ANALYZER