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 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

There was no additional patient information provided by the customer due to privacy issues.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated architect afp results on one patient.The results provided were: sid203 = 57.36ng/ml (reference range 0.89-8.78ng/ml) / retest the next day sid201 = 1.70ng/ml.The customer is unable to provide any patient diagnosis.There was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation for a false elevated afp result included a search for similar complaints, and review of complaint text, trending data, labelling, and device history records review.Return testing was not completed as returns were not available.Performance of complaint reagent lot was evaluated using world wide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for complaint lot is within the established control limits, therefore, no unusual reagent lot performance was identified.Lot and trending review did not identify an increase in complaint activity for the lot for the issue and no related trend for the issue for the product.Device history record review on complaint lot did not show any potential non-conformances, or deviations.Labelling was reviewed and found to adequately address the issue under review.Based on the evaluation, no systemic issue or product deficiency of the architect afp assay was identified.

• 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
• MDR Report Key: 12158535
• MDR Text Key: 261486517
• Report Number: 3008344661-2021-00138
• 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
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2021
• Device Catalogue Number: 03P36-78
• Device Lot Number: 18458FN01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).