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

Catalog Number 03P36-26

Device Problem High Test Results (2457)

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

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

The customer observed a single false elevated afp results using architect afp, list 3p36-25 ((b)(4) list number 3p36-26), lot 54021lh00.The ticket searches determined normal complaint lot and no trend for the issue for the product.Historical performance of lot 54021lh00 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 this lot is within the established control limits and no unusual reagent lot performance was identified.A review of the manufacturing documentation for the lot did not identify any issues associated with the customer observation.A review of labeling concluded that the issue is sufficiently addressed.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, a systemic issue and/or product deficiency was not identified.

Event Description

The customer stated that the architect analyzer generated a falsely elevated afp result on one patient after surgery.The results provided were: (b)(6) 2016 = 18ng/ml / previously (unknown date) 5.0ng/ml / (b)(6) 2016 = 5.6ng/ml.There was no additional patient information provided.There was no reported impact to patient management.

• 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: 6519924
• MDR Text Key: 74014807
• Report Number: 3008344661-2017-00037
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2016
• Device Catalogue Number: 03P36-26
• Device Lot Number: 54021LH00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• 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 # 03M74-01,; SERIAL # (B)(4)