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

Model Number	3P36-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9935530
• Report Number: 3008344661-2020-00028
• Device Sequence Number: 2717627
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR PROCESSING MODULE; ARCHITECT I2000SR, LIST 3M74-01,; LIST # 03M74-01, SN (B)(6) ; SERIAL (B)(6)