MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS AFINION 2; ANALYSER

Model Number	1116986
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 the customer sent technical services (ts) an email, their afinion 2 (sn (b)(6)) was smelling very hot and smoking while running a test.The customer had already unplugged the machine and stopped using it.On (b)(6) 2024 customer confirmed: the power cord was black and blue color with serial no.(b)(6).There was a small amount of smoke, the location from where it cam could not be identified and the hot smell was like burning plastic.In addition to this the customer also confirmed there was a terrible noise from the instrument.Customer confirmed the incident did not cause death or any injury.The instrument was set up in a suitable environment.
Additional Manufacturer Narrative
There were no adverse patient effects and no clinically significant delay in the procedure reported in the complaint.The complaint details were reviewed along with our internal records.No observations from the internal investigation could explain the development of smoke or warm odor.The issue reported could not be verified internally, and the cause could not be identified.The returned instrument was tested on (b)(6) 2025, the instrument passed all inspection.Heat on the main printed board assembly (pba) was within normal range.Instrument was dispositioned as scrap due to unknown cause of complaint.
Event or Problem Description
On 02 oct 2024 the customer sent technical services (ts) an email, that their afinion 2 (sn (b)(6)) was smelling very hot and smoking while running a test.The customer had already unplugged the machine and stopped using it.The customer later added that they were not able to see where the small amount of smoke was coming from, but could smell hot plastic and the instrument was making a terrible noise.On 03 oct 2024 customer confirmed: - the power cord was black and blue color with serial no.(b)(6).- there was a small amount of smoke, the location from where it came could not be identified and the hot smell was like burning plastic.In addition to this the customer also confirmed there was a terrible noise from the instrument.Customer confirmed the incident did not cause death or any injury.The instrument was set up in a suitable environment.

• Brand Name: AFINION 2
• Common Device Name: ANALYSER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo NO-05 04; NO NO-0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo NO-05 04; NO NO-0504
• Manufacturer Contact: claire dora ; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo NO-05-04 ; NO NO-0504 ; 24056000
• MDR Report Key: 20531136
• Report Number: 9613069-2024-00005
• Device Sequence Number: 17812927
• Product Code: JQT
• UDI-Device Identifier: 07070060014708
• UDI-Public: 07070060014708
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K182988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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 Model Number: 1116986
• Device Catalogue Number: 1116986
• Device Lot Number: 10439635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown