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 Type  malfunction  

Event Description

The customer stated that the architect generated a falsely elevated afp result on one patient.The results provided were: (b)(6) initial = 625ng/ml / 5.73 / retest = 6.0 / 5.8ng/ml.There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, accuracy testing, a review of labeling, and a review of the manufacturing records.The customer observed a falsely elevated afp result while using architect afp, list number 3p36-25, lot 40168lf00.A review of complaints determined that there is no unusual activity for lot 40168lf00.Testing of a serum panel which mimics a patient sample, was performed and all acceptance specifications were met indicating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues during the manufacturing of this lot.A review of labeling was performed and the architect afp reagent package insert adequately addresses sample handling.Based on the information in this investigation, no product deficiency was identified for afp lot 40168lf00, and there is not enough information to reasonably suggest a malfunction occurred.

• 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: 4340501
• MDR Text Key: 5202865
• Report Number: 3008344661-2014-00045
• 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,Followup
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2014
• Device Catalogue Number: 03P36-26
• Device Lot Number: 40168LF00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,