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

Catalog Number 03P36-77

Device Problem High Test Results (2457)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 results for two samples.The following data was provided: sid (b)(6), intial request = (b)(6), repeat = (b)(6), (b)(6) results are within normal range sample 2: intial request = (b)(6), repeat within normal range.It is unknown if the patients have been diagnosed with (b)(6) or if they are pregnant between 15 to 21 weeks gestation.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated architect afp results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any potential non-conformances, deviations, or non-conformances with lot 28181fn01 and the complaint issue.The overall performance of architect cea was reviewed using field data from customers worldwide.Shows that the median patient result for lot 28181fn00 (28181fn01) falls within established baselines, indicating the reagent lot is performing acceptably on market.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the architect afp reagent for lot 28181fn01 was identified.Section g1 has been updated to current contact information.

Event Description

The customer observed falsely elevated architect afp results for two samples.The following data was provided: sid (b)(6) initial result = 192, repeat = 2.21, cea and ca199 results are within normal range sample 2: initial result = 538, repeat within normal range.It is unknown if the patients have been diagnosed with nonseminomatous testicular cancer or if they are pregnant between 15 to 21 weeks gestation.No impact to patient management was reported.

• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13022207
• MDR Text Key: 290148167
• Report Number: 3008344661-2021-00213
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2022
• Device Catalogue Number: 03P36-77
• Device Lot Number: 28181FN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2021
• 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, ISR64501; ARC I2000SR INST, 03M74-02, ISR64501