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 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: patient identifier: (b)(6).Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated architect afp result for 1 sample.The following data was provided: on (b)(6) 2019 sid (b)(6) initial result = 157 ng/ml, repeats = 8.7 ng/ml, 9.2 ng/ml.Patient's history = 10 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 01476fn00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing was performed using an in-house retained kit of lot 01476fn00 and all specifications were met indicating the lot is preforming acceptably.Historical performance of reagent lot 01476fn00 using world wide data was evaluated.The patient median result for the lot is comparable with all other lots in the field and confirms no systemic issue for the lot.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect afp for lot 01476fn00 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: 8916240
• MDR Text Key: 159248903
• Report Number: 3008344661-2019-00106
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• 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
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 03P36-26
• Device Lot Number: 01476FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST 03M74-01; ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4)