MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS ALERE AFINION AS100 ANALYZER

Model Number	1115390
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device requested, but not yet returned.
Event or Problem Description
On (b)(6) 2024 a customer called to report error code 214 (test cartridge or analyzer failure) and provided the following product details: analyzer serial number: (b)(6).Software version: 7.03.Cartridge type: hba1c.Cartridge lot number: not provided.There were no known shipping concerns or environmental condition concerns.The temperature in the facility was reported to be 68-70 degrees fahrenheit ( 20-21 degrees celsius).Frequency of failed assays: 3-4 times.Customer also reported that tech went over to service the afinion instrument, and there was a visible electrical spark from the cord.The incident did not trip the circuit breaker, and the cord was not plugged into a surge protector.Tech stopped working on the analyzer immediately and called technical services (ts) for assistance.No one was touching or using the analyzer when the spark occurred.The tech was wearing rubber soled shoes, short sleeve shirt and pants.There was no attempt to use the instrument after sparking.The tech was advised not to use the instrument after the sparking event.On january 25, 2024 additional information was received that the customer was using the old power supply (model # fra042-f24-8).
Event or Problem Description
On january 24, 2024 a customer called to report error code 214 (test cartridge or analyzer failure) and provided the following product details: analyzer serial number: (b)(6).Software version: 7.03.Cartridge type: hba1c.Cartridge lot number: not provided.There were no known shipping concerns or environmental condition concerns.The temperature in the facility was reported to be 68-70 degrees fahrenheit ( 20-21 degrees celsius).Frequency of failed assays: 3-4 times.Customer also reported that tech went over to service the afinion instrument, and there was a visible electrical spark from the cord.The incident did not trip the circuit breaker, and the cord was not plugged into a surge protector.Tech stopped working on the analyzer immediately and called technical services (ts) for assistance.No one was touching or using the analyzer when the spark occurred.The tech was wearing rubber soled shoes, short sleeve shirt and pants.There was no attempt to use the instrument after sparking.The tech was advised not to use the instrument after the sparking event.On january 25, 2024 additional information was received that the customer was using the old power supply (model # fra042-f24-8).
Additional Manufacturer Narrative
Upon completion of investigation it was observed that lot number has changed.

• Brand Name: ALERE AFINION AS100 ANALYZER
• 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 (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o. box 6863, rodeløkka; oslo 0884 ; NO 0884
• Manufacturer Contact: claire dora ; kjelsåsveien 161; p.o. box 6863, rodeløkka; oslo NO-05-04 ; NO NO-0504 ; 90756000
• MDR Report Key: 18729398
• Report Number: 9613069-2024-00001
• Device Sequence Number: 17906255
• Product Code: JQT
• UDI-Device Identifier: 07070060008042
• UDI-Public: 07070060008042
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K180269
• 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 Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: Other
• Device Model Number: 1115390
• Device Catalogue Number: 1115390
• Device Lot Number: 10205656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2017
• 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