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

Catalog Number	07P90-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity i afp generated from alinity i processing module and provided the following data: customer normal range: 0.9 - 8.8 ug/l.On (b)(6): sample id: (b)(6) (patient from health screening), 1st run (b)(6): 13.4, 2nd run (b)(6): 2.6, 3rd run (b)(6): 2.6.On (b)(6): sample id: (b)(6) (patient from ent clinic), 1st run (b)(6): 11.7, 2nd run (b)(6): 8.0, 3rd run (b)(6): 7.4.On (b)(6): sample id: (b)(6) (patient from gastrointestinal clinic), 1st run (b)(6): 26, 2nd run (b)(6): 2.9, 3rd run (b)(6): 3.3.No other patient information was provided.There was no reported impact to patient management.A1 patient identifier: complete list of sample id's are (b)(6).
Additional Manufacturer Narrative
A1 patient identifier: complete list of sample id's are (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated alinity i afp generated from alinity i processing module and provided the following data: customer normal range: 0.9 - 8.8 ug/l.(b)(6): sample id: (b)(6), (patient from health screening).1st run (b)(6): 13.4, 2nd run (b)(6): 2.6, 3rd run (b)(6): 2.6.On (b)(6): sample id: (b)(6), (patient from ent clinic).1st run (b)(6): 11.7, 2nd run (b)(6): 8.0, 3rd run (b)(6): 7.4.On (b)(6): sample id: (b)(6), (patient from gastrointestinal clinic).1st run (b)(6): 26.2nd run (b)(6): 2.9.3rd run (b)(6): 3.3.No other patient information was provided.There was no reported impact to patient management.
Additional Manufacturer Narrative
Section b5 was corrected.After further evaluation, the suspect medical device was changed from alinity i afp reagent kit , list number: 07p90-20, and manufacturing site abbott ireland diagnostics division finisklin business park, sligo, f91vy44, ireland to alinity i processing module, ln 03r65-01, abbott laboratories, 1915 hurd drive, irving, tx, 75038.Mdr number 3016438761-2025-00166 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ALINITY I AFP REAGENT KIT
• Common Device Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21509097
• Report Number: 3008344661-2025-00023
• Device Sequence Number: 7974275
• Product Code: LOK
• UDI-Device Identifier: 00380740130817
• UDI-Public: (01)00380740130817(17)250508(10)64390FZ00
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 07P90-20
• Device Lot Number: 64390FZ00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown