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

Model Number	3P36-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
The customer observed a falsely elevated afp result on the architect i2000sr analyzer.The following data was provided: initial 4, repeated an aliquot at 1704, and again from the original sample as 3 ng/ml and 4 ng/ml.There was no 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, review of field data, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.No patient sample was available to assist in the investigation.Therefore, testing of a serum based panel sample with a target concentration of 20 ng/ml, which mimics a patient sample, was performed using an in-house retained kit of lot 76329fn00 stored at the recommended storage condition.All specifications were met indicating that lot 76329fn00 is performing acceptably.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was 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: 7130508
• Report Number: 3008344661-2017-00106
• Device Sequence Number: 11076699
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: (01)00380740112400(17)180502(10)76329FN00
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: 05/02/2018
• Device Model Number: 3P36-35
• Device Catalogue Number: 03P36-35
• Device Lot Number: 76329FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1