MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT AFP; ALPHA-FETOPROTEIN

Model Number 3P36-25

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No specific patient information was provided.

Event Description

The customer obtained a falsely elevated architect afp result.The sample generated an initial result of 79.2 ng/ml and repeat 2.51 ng/ml.The customer indicated the patient's previous result was 2.4 and 2.6 ng/ml.No specific patient information was available.No impact to patient management was reported.

Manufacturer Narrative

Review of ticket searches determined there was normal complaint activity for lot 07003fn00.No other complaints were identified.Complaint trending reports for the architect afp assay was reviewed and determined that there were no trends associated with the complaint issue.Worldwide field data was used to assess the performance of the reagent lot.The median patient result for lot 07003fn00 was within the established baselines and comparable with all other lots in the field, confirming no systemic issue for the lot.Review of the product quality history for the lot did not identify any issues associated with the customers observation.Additionally, labelling was reviewed which adequately addresses the issue.No systemic issue or deficiency of the architect afp assay was identified.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9935530
• MDR Text Key: 208765888
• Report Number: 3008344661-2020-00028
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: 3P36-25
• Device Catalogue Number: 03P36-25
• Device Lot Number: 07003FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR PROCESSING MODULE; ARCHITECT I2000SR, LIST 3M74-01,; LIST # 03M74-01, SN (B)(6) ; SERIAL (B)(6)