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

Catalog Number 03P36-25

Device Problem High Test Results (2457)

Patient Problem Test Result (2695)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

The customer reports a falsely elevated architect afp assay result for one male oncology patient (testicular cancer).The patient has been undergoing chemotherapy that ended in (b)(6) 2014 and through the months of (b)(6) 2014 had been generating afp results of around 3.70 ng/ml.The patient returned in april for a check up to schedule an operation for a residual mass and generated an architect afp assay result of 21.0 ng/ml on (b)(6) 2014.A pet-ct scan was performed and was found to be normal.On (b)(6) 2014, a new sample from this patient generated an architect afp result of 3.40 ng/ml.There is no further 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

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 was conducted across three architect isystems.Sixteen replicates of a medium values afp panel were tested on each isystem.All results met specifications.There is not enough information to reasonably suggest that a malfunction occurred as the elevated result generated is for a discrete patient sample and a re-draw taken within close proximity shows the correct result, i.E.Expected low result of 3.4ng/ml.The single elevated result of 21 ng/ml obtained for the patient sample is potentially due to sample integrity/sample handling issues at the time of testing.Based on the results of the current product evaluation and the information from the customer site, it was determined that the architect afp assay, lot number 32146lf00 is performing acceptably.A product malfunction was not identified.

• 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 ; 847937-512
• MDR Report Key: 3812417
• MDR Text Key: 15328775
• Report Number: 3008344661-2014-00024
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• 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: 03P36-25
• Device Lot Number: 32146LF00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR LN:03M74-02, SN: (B)(4); ARCHITECT I2000SR LN:03M74-02, SN: (B)(4)