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

Catalog Number 03P36-77

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the design history file, review of field data, and a review of labeling.No adverse trend, non-conformances, potential non-conformances, or deviations were identified for the customer's issue.No return patient sample was available.Labeling was reviewed and found to be adequate.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within expected limits.Accurate and reproducible results are dependent upon properly functioning instruments and reagents, storage of product as directed, and good laboratory technique.Based on all available information and abbott diagnostics' complaint investigation, no product deficiency was identified.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated afp results on the architect i2000sr analyzer.The following data was provided for a patient with an unknown diagnosis: initial 1589.5 ng/ml, repeat 9.9 ng/ml.There was no impact to patient management reported.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 9521630
• MDR Text Key: 190689217
• Report Number: 3008344661-2019-00157
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Catalogue Number: 03P36-77
• Device Lot Number: 04061FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1