MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP ASSAY

Catalog Number 03P36-20

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

The customer initially reported a falsely decreased architect afp assay result generated on an architect i2000sr analyzer.A plasma sample taken from the patient generated a result of 0.69 ng/ml.A serum sample (139s) taken from the same patient generated a result of 1.41 ng/ml.Controls have remained within specifications.Both samples were retested four days later with the following results: plasma sample: 0.72, 0.70 and 0.72 ng/ml; serum sample: 0.80, 0.77 and 0.76 ng/ml.No suspect results were reported from the lab with no patient impact.

Manufacturer Narrative

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

Manufacturer Narrative

A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The architect afp assay package insert contains information to address the current customer issue.Accuracy testing employing a low panel sample targeted at 20 ng/ml was performed across three architect isystem platforms.All results met specifications, indicating that the lot in question is performing acceptably.Instrument performance was verified at the customer site.This is an instance of off-label use of the architect afp assay.There is no data in the reagent package insert for the lung cancer disease state and it is also not included in the intended use section of the insert.Also, the plasma tube with gel documented as being used by the customer in the collection of the sample used for assay testing, has not been verified for use with the architect afp assay.Additional information from the customer site revealed that the customer conducted an internal investigation that concluded, with a very high probability, that a patient sample handling error had occurred.Also, the customer is using the assay for diagnostic purposes and not monitoring.Based on the results of the current product evaluation and the information from the customer site, it was determined that the architect afp assay, list number 03p36-20, lot number 34309lf00 is performing acceptably.A product malfunction was not identified.This patient was diagnosed with lung cancer.

• Brand Name: ARCHITECT AFP ASSAY
• Type of Device: AFP
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3625423
• MDR Text Key: 15810394
• Report Number: 3008344661-2014-00009
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P120008
• 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: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/14/2014
• Device Catalogue Number: 03P36-20
• Device Lot Number: 34309LF00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR: LN:03M74-97 SN: (B)(4); ARCHITECT I2000SR: LN:03M74-97 SN: (B)(4)