MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP REAGENT KIT; KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Catalog Number 03P36-78

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

The customer reported a falsely elevated architect afp result for a male patient with unknown clinical history.The initial afp result was 65 ng/ml and when retested generated a result of 16.92 ng/ml (reference range is < 13.6 ng/ml).There was no impact to patient management reported.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint investigation for false elevated architect afp results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Data and information provided by the customer confirm the complaint issue without indication for any additional issue identified.A ticket search by lot number indicates the product lot is performing as expected.A review of tracking and trending data for the product did not identify any commonalities regarding the lot number 43036fn00 and complaint issue.No related trends were identified.A review of the device history record did not identify any potential non-conformances, deviations, or non-conformances for the associated lot number 43036fn00 and complaint issue.Accuracy testing was performed using an in-house retained kit of the complaint lot 43036fn00.Testing met acceptance criteria and the product is performing as expected.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect afp reagent lot 43036fn00.Correction to d4 - catalog no: initial: 03p36-74 / corrected: 03p36-78.

• Brand Name: ARCHITECT AFP REAGENT KIT
• Type of Device: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16374181
• MDR Text Key: 309593289
• Report Number: 3008344661-2023-00038
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P120008
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2023
• Device Catalogue Number: 03P36-78
• Device Lot Number: 43036FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR63789.; ARC I2000SR INST, 03M74-02, ISR63789.
• Patient Sex: Male