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

Model Number 3P36-25

Device Problem High Test Results (2457)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a false elevated architect afp result for a (b)(6) year old female.The following data was provided on (b)(6) 2021: sid (b)(6) = initial result = 789.08 ng/ml, repeat result = 2.04 ng/ml there was no impact to patient management reported.

Manufacturer Narrative

Component code: g01003.The complaint investigation for a false positive architect afp results included a search for similar complaints, and review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Historical performance of reagent lot 18455fn01 was evaluated using worldwide data from customer field data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 18455fn01 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Trending review determined no trends identified for the issue for the product.Device history record review on lot 18455fn01 did not show any non-conformances or deviations.After further troubleshooting from the customer, the customer noticed a lot of serum crystals around the sample tube opening.When the crystals were dissolved in water and tested for afp a result of 189 was generated.The positive result may have been due to serum crystals falling into the sample.For accurate results, serum and plasma specimens should be free of fibrin, red blood cells, and other particulate matter.Serum specimens from patients receiving anticoagulant or thrombolytic therapy may contain fibrin due to incomplete clot formation.Use caution when handling patient specimens to prevent cross contamination.Use of disposable pipettes or pipette tips is recommended.To ensure consistency in results, specimens must be transferred to a centrifuge tube and centrifuged at =10,000 rcf (relative centrifugal force) for 10 minutes before testing if they contain fibrin, red blood cells, or other particulate matter or they were frozen and thawed.Centrifuged specimens with a lipid layer on the top must be transferred to a sample cup or secondary tube.Care must be taken to transfer only the clarified specimen without the lipemic material.Transfer clarified specimen to a sample cup or secondary tube for testing.Labeling was reviewed and found to adequately address the issue under review.Review of the incident and labeling confirmed the architect afp product was not in alignment.The architect afp package insert clearly indicates that the intended use of the product is as an aid in monitoring disease progression during the course of disease and treatment of patients with nonseminomatous testicular cancer and also to aid in the detection of fetal open neural tube defects (ntd).Based on the investigation, no systemic issue or deficiency of the architect afp assay, lot number 18455fn01 was identified.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• 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: 11408450
• MDR Text Key: 266420685
• Report Number: 3008344661-2021-00050
• 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,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• 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 Model Number: 3P36-25
• Device Catalogue Number: 03P36-25
• Device Lot Number: 18455FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• 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) ; ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 9 YR