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

Catalog Number 02K45-25

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reports that an aliquot of one patient's sample was taken from the initial collection tube and tested with the architect ca125 ii assay on an architect i2000 analyzer (sn (b)(4)).Results of 159.5 and 156.3 u/ml were generated with reagent lot 39018m500.The aliquot was recentrifuged and tested on a second architect i2000 analyzer (sn (b)(4)) and generated results of 23.0 and 23.3u/ml with reagent lot 41540m500.This is the only patient sample to exhibit this phenomenon.There were no significant differences in calibration curves between the two analyzers.The sample was sent to a reference lab.A result of 160.8 u/ml was generated on an architect isystem using reagent lot 39018m500 and a result of 20.5 u/ml was generated with lot 41540m500.A dilution study was also performed (reagent lot 39018m500) with the following results: 1:2 = 249.6 u/ml; 1:4 = 326.4 u/ml; 1:8 = 375.2 u/ml; 1:16 = 387.2; 1:32 = 284.8 u/ml.Treatment of the sample with a heterophilic antibody: treated = 10.7 u/ml and untreated = 6.7 u/ml.There is 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).

Manufacturer Narrative

There were no returns available from the customer site for this evaluation.Accuracy testing was performed using an in-house retained reagent kit of lot 39018m500.One isystem analyzer was successfully calibrated and replicates of a ca 125 panel set (1 - 3) were tested.All results met acceptance specifications, indicating acceptable performance of the assay lot.The architect ca125 ii assay package insert contains information to address the current customer issue.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.The issue was confined to one discreet patient sample, which further evaluation by the customer indicated the presence of a heterophilic antibody.No additional issues were 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: 4585997
• MDR Text Key: 18027565
• Report Number: 1415939-2015-00003
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2015
• Device Catalogue Number: 02K45-25
• Device Lot Number: 39018M500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000 ANALYZER LN: 08C89-01; (B)(4); (B)(4); ARCHITECT I2000 ANALYZER LN: 08C89-01