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

Catalog Number 03P36-30

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that the architect analyzer generated falsely elevated afp results on one patient.The results provided were: initial 993.96 / repeated = 3.21.There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

The customer observed a single false elevated afp result using architect afp, list 3p36-30, lot 64393fn00.No patient sample was available to assist in the investigation.The complaint text states that the customer measured afp for a patient who was not diagnosed with testicular cancer or was at 15 to 21 weeks gestation.The information provided indicates that the afp assay was used for screening which was not in alignment with the afp assay labeling.Historical performance of list 3p36 was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 64393fn00 is within the established control limits and no unusual reagent lot performance was identified.No adverse trend was identified for the customer's issue.A review of complaints determined that there is no unusual complaint activity for lot 64393fn00.Accuracy testing was performed with a file sample of lot 64393fn00 and a serum based panel sample and all specifications were met indicating that lot 64393fn00 is performing acceptably.A review of the manufacturing records for this lot did not identify any issues associated with the customer observation.A review of assay labeling and the architect operations manual shows adequate information is provided to address discrepant results including sample integrity/ sample handling issues.Based on the investigation no product deficiency was identified.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.

• 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: 6253088
• MDR Text Key: 64917064
• Report Number: 3008344661-2017-00004
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2017
• Device Catalogue Number: 03P36-30
• Device Lot Number: 64393FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4)