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

Model Number	1116985
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/an/a device not yet returned.
Event or Problem Description
13-nov-2023: the technical consultant emailed technical services (ts).The customer reported spark coming from the cartridge holder/compartment of their afinion 2, right after there was a smell of burnt.We have powered off the machine.The customer also provided the following information: serial number: (b)(6).   software version: w 21.14  no harm to user circuit breaker did not trip.
Additional Manufacturer Narrative
As of 11.02.2025 the instrument has not been received by the legal manufacturer for further investigation.Customer reported some sort of spark coming from the cartridge holder/compartment of the afinion 2 serial number (b)(6) (sw: 21.14).Right after there was a smell of burnt.The analyzer was powered off after the event.No harm reported.The following steps were taken by the manufacturer: review of (b)(6) history records; similar complaint trend analysis; product risk review; review of non-conformance data.The complaint details were reviewed along with internal records.There were no adverse patient effects and no clinically significant delay in the procedure reported in the complaint.Our investigation determined that there is no indication that the reported issue is related to product results, inadequate instructions for use or inaccurate labeling.Our investigation did determine that the spark allegations was a led light flash from inside the cartridge chamber, which is considered normal behavior when removing the power cable from the instrument.It is not possible for the inside of the instrument to produce a spark.The event of the burnt smell was determined to be caused by an analyzer failure.Furthermore, it should be noted that the analyzer might be impaired by the following: condensing humidity and water, heat and large temperature variations, direct sunlight, vibrations (e.G.From centrifuges and dishwashers), electromagnetic radiation, movement of the analyzer during processing of a test cartridge.
Event or Problem Description
13-nov-2023: the technical consultant emailed technical services (ts).The customer reported spark coming from the cartridge holder/compartment of their afinion 2, right after there was a smell of burnt.We have powered off the machine.The customer also provided the following information: serial number: (b)(6).Software version: w 21.14.No harm to user.Circuit breaker did not trip.
Additional Manufacturer Narrative
Inspection of the instrument was performed and concluded 29.07.2025.The overall inspection passed, however the instrument will be scrapped according procedure due to complainant observation of sparks and electrostatic.
Event or Problem Description
13-nov-2023: the technical consultant emailed technical services (ts).The customer reported spark coming from the cartridge holder/compartment of their afinion 2.Right after there was a smell of burnt.The customer powered off the machine.The customer also provided the following information: serial number: (b)(6).Software version: sw 21.14.No harm to user.Circuit breaker did not trip.

• Brand Name: AFINION 2
• Common Device Name: ANALYSER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; po box 6863 rodelokka; oslo N0-05 04; NO N0-0504
• Manufacturer Contact: claire dora ; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05-04 ; NO NO-0504 ; 24056000
• MDR Report Key: 18158356
• Report Number: 9613069-2023-00005
• Device Sequence Number: 12758047
• Product Code: JQT
• UDI-Device Identifier: 07070060014692
• UDI-Public: 07070060014692
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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
• Device Model Number: 1116985
• Device Catalogue Number: 1116985
• Device Lot Number: 10936921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 02/20/2025; 07/29/2025
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 03/18/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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
• Patient Sex: Unknown