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

Catalog Number	03P36-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was not provided by the customer; therefore, only a partial udi is known an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in-process.
Event or Problem Description
The customer observed a falsely elevated afp result for one patient while using the architect afp assay.The customer provided the following data (ng/ ml): (b)(6) 2017: sid (b)(6): initial: 50.89, retest after centrifugation: 31.11.The specimen from (b)(6) 2017 was retested on (b)(6) 2017: retests: 6.28 and 6.01 a second specimen was tested on (b)(6) 2017: initial 4.11 ng/ml there was no adverse impact to patient management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, design history record (dhr) review, and a review of labeling.Tracking and trending did not identify an adverse trend or any atypical complaint activity.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information a deficiency of the architect afp reagent, list 03p36, was not identified.

• Brand Name: ARCHITECT AFP
• Common Device Name: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 6755014
• Report Number: 3008344661-2017-00072
• Device Sequence Number: 131782
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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 Catalogue Number: 03P36-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1