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

Catalog Number 03P36-25

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated afp results on the architect i1000sr analyzer.The following data was provided: sid (b)(6), initial 48.60, repeats 12.33, 3.12 ng/ml , sid (b)(6), initial 34.64, repeats 6.48, 2.57 ng/ml there was no impact to patient management reported.

Manufacturer Narrative

The likely cause size code was updated on may 8, 2019 from 03p36-26 to 03p36-25.An evaluation is still in process.A final report will be submitted when the evaluation is completed.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.Testing could not be completed as reagent lot 88061fn00 has expired 17april2019.No return patient sample was available.Historical performance of the reagent lot 88061fn00 was evaluated using world wide data.The patient data was analyzed and within expected limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8567534
• MDR Text Key: 151153290
• Report Number: 3008344661-2019-00061
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• PMA/PMN Number: P120008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Catalogue Number: 03P36-25
• Device Lot Number: 88061FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER; LN 01L86-01 SN (B)(4) ; LN 01L86-01 SN (B)(4) ; LN 01L86-01 SN (B)(4)