MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS AFINION AS100 ANALYZER US VERSION RFB

Model Number	1115390
Medical Device Problem Codes	Failure of Device to Self-Test (2937); Noise, Audible (3273); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date has been set at 08 nov 2025, however the issue happened over the weekend and the exact date has not been provided.Multiple attempts to obtain the event date have been made, they have been unsuccessful.Return and replacement initiated.Customer initiated return of as100 analyzer on 13 nov 2025, and is not yet received by the manufacturer.
Event or Problem Description
10nov2025: customer phoned technical services (ts) informing that one of their providers emailed about afinion instrument, (sn: (b)(6), making a loud noise upon start up, they tried unplugging and plugging it back in but the red light was blinking, the screen then displayed a self-test error, the analyzer was in a none-operative mode.The customer also reported that one of the providers also informed that it almost shocked them, probably when they are unplugging/plugging it.This only happened with 1 provider, as what the customer recalled.Customer later clarified that electrical shock was from the power supply and they touched the machine and did not experience any electrical shock.
Additional Manufacturer Narrative
The event date has been set at 08 nov 2025, however the issue happened over the weekend and the exact date has not been provided.Multiple attempts to obtain the event date have been made, they have been unsuccessful.Return of as100 analyzer and replacement with afinion analyzer (current model) has been completed.The complaint details were reviewed along with internal records.The afinion products were returned and inspected, which concluded that the event of the potential electrical shock was due to a failure with the power supply, connected with the alere afinion as100 analyzer.There were no faults identified with the instrument itself.The overall inspection on the performance of the product passed.It is important to ensure that the alere afinion as100 analyzer is placed on a dry, clean, stable and horizontal surface.Make sure that the analyzer is located with sufficient surrounding airspace, at least 5 inches on each side.Acclimate the analyzer to ambient operating temperature (15-32°c, 59-89°f).The analyzer might be impaired by: 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, use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause electrostatic discharge.Connect the power cable to the power cord adapter.Insert the plug from the power cord adapter into the power socket in the back of the analyzer.Plug in the power cord to a wall outlet.
Event or Problem Description
On (b)(6) 2025: customer phoned technical services (ts) informing that one of their providers emailed about afinion instrument, (sn (b)(6), making a loud noise upon start up, they tried unplugging and plugging it back in but the red light was blinking, the screen then displayed a self-test error, the analyzer was in a none-operative mode.The customer also reported that one of the providers also informed that it almost shocked them, probably when they are unplugging/plugging it.This only happened with 1 provider, as what the customer recalled.Customer later clarified that electrical shock was from the power supply and they touched the machine and did not experience any electrical shock.It was also confirmed that there are no sparks, no smoke, and no burning in the machine.A mascot (black and blue) power supply was used (serial number/date code not provided), with the mains cord plugged to a main outlet.The circuit breaker did not trip.No other instances of static electricity had been experienced.The instrument was placed in a dry environment.

• Brand Name: AFINION AS100 ANALYZER US VERSION RFB
• Common Device Name: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo NO-05 04; NO NO-0504
• Manufacturer Contact: maja øverby ; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo NO-05-04 ; NO NO-0504 ; 24056000
• MDR Report Key: 23715128
• Report Number: 9613069-2025-00005
• Device Sequence Number: 8910425
• Product Code: JQT
• UDI-Device Identifier: 07070060008042
• UDI-Public: (01)07070060008042
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 1115390
• Device Catalogue Number: 1115390
• Device Lot Number: 10218473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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