MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP; ALPHA-FETOPROTEIN

Catalog Number 03P36-30

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2015

Event Type  malfunction  

Event Description

The customer reports a falsely elevated architect afp assay result of 80.27 ng/ml generated on an architect i2000sr analyzer (serial number (b)(3)) in their laboratory.The sample was then tested on another architect i2000sr analyzer in their laboratory, which generated a result of 2.77 ng/ml that the customer believes to be correct.The customer states that this is an intermittent issue and is not related to any specific lot of reagent.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

No returns were made available from the customer site for this evaluation.Accuracy testing was performed using a retained kit of architect afp assay lot 46114lf00 across three architect isystems by running 16 replicates each of an afp low panel sample on each analyzer.All results met specifications indicating acceptable product performance.A review of data from the customer site along with instrument logs downloaded from the analyzer found no unusual performance issues.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 and the architect operation manual both contain information to address the current customer issue.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 addressed through standard troubleshooting procedures.Catalog#, corrected from 03p36-20 to 03p36-30.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• 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 ; 224667-512
• MDR Report Key: 4712423
• MDR Text Key: 5649359
• Report Number: 3008344661-2015-00010
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2015
• Device Catalogue Number: 03P36-30
• Device Lot Number: 46114LF00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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); ARCHITECT I2000SR ANALYZER LN:03M74-02; SN: (B)(4)