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

Model Number	07P9020
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device service by a third party? no.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely decreased alinity i afp result on a patient.Results provided: (b)(6) 2021 sid (b)(6) = 13 / > 1660 / > 1660 / x10 dilution = 5823 / 5800 iu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets was performed for the likely cause alinity i afp reagent lot number 23244fn00.The ticket search determined that there is normal complaint activity for this lot number.Testing was performed in-house using a retained kit of lot# 23244fn00 and all specifications were met, indicating the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency was identified for the alinity i afp reagent lot number 23244fn00.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• Brand Name: ALINITY I AFP REAGENT KIT
• Common Device Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 11778278
• Report Number: 3008344661-2021-00100
• Device Sequence Number: 11869027
• Product Code: LOK
• UDI-Device Identifier: 00380740130817
• UDI-Public: 00380740130817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/15/2021

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: 12/13/2021
• Device Model Number: 07P9020
• Device Catalogue Number: 07P90-20
• Device Lot Number: 23244FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI01400; ALNTY I PROCESSING MODU, 03R65-01, AI01400