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

Model Number	1116985
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 14 feb 2025 abbott technical consultant (tc) called technical services (ts) to report an issue from a customer.The customer had informed tc of the following; when they came in this morning, their 2 afinion 2 instruments (both sitting on a counter) were fine.When someone came in the room, they noticed that there was something leaking (like black coffee) underneath the 1 analyzer.When they noticed it, the instrument suddenly shut off.The instruments involved were: (b)(6) - instrument in question.(b)(6) - working fine.Ts contacted the customer and received the following update: just to summarize - we had 1 of the a1c machines off on its own when i came in this morning and a leak that looked like a coffee stain underneath both machines.When further examining, saw the battery pack of one of the machines was leaking battery acid.It also sparked in the process.We shut off the whole power supply in that area and had our biomed department come over and assess the spill.They removed the battery packs from both machines and said we need those replaced.I am afraid we might need both machines replaced as they were both sitting in the battery acid and am unsure what was damaged.The customer also mentioned that there was a quick spark on the cord and when they unplugged them, there was a quick burnt smell.Customer confirmed again that there was no harm or injury due to the event.On (b)(6) 2025, the customer confirmed they were referring to the power supply of the afinion instrument, not an external battery.Customer stated that the "leak" was coming from the power supply of the afinion 2 instrument serial number (b)(6).Both instruments were plugged in when they noticed the "leak stain" where the instruments were sitting on.Customer noticed the quick spark and quick burnt smell when they unplugged the (b)(6); the spark was coming from the power supply plug, not the analyzer.
Additional Manufacturer Narrative
Return of analyzer and power supplies initiated.
Additional Manufacturer Narrative
The complaint details were reviewed along with internal records and no nonconformances were identified.Power supplies are not batteries and do not contain batteries; they convert ac to dc, meaning their main components are electronic.Therefore, a power supply cannot leak.The most probable cause is user related.Physical inspection of the returned instrument showed no issues, and no leakage inside the instrument was observed.The electrical exposure was assessed to be caused by the already spilled liquids (most likely spilled coffee).
Event or Problem Description
On 14 feb 2025 abbott technical consultant (tc) called technical services (ts) to report an issue from a customer.The customer had informed tc of the following; when they came in this morning, their 2 afinion 2 instruments (both sitting on a counter) were fine.When someone came in the room, they noticed that there was something leaking (like black coffee) underneath the 1 analyzer.When they noticed it, the instrument suddenly shut off.The instruments involved were: - af20081867 - instrument in question.- af20080682 - working fine ts contact the customer and received the following update: just to summarize - we had 1 of the a1c machines off on its own when i came in this morning and a leak that looked like a coffee stain underneath both machines.When further examining, saw the battery pack of one of the machines was leaking battery acid.It also sparked in the process.We shut off the whole power supply in that area and had our biomed department come over and assess the spill.They removed the battery packs from both machines and said we need those replaced.I am afraid we might need both machines replaced as they were both sitting in the battery acid and am unsure what was damaged.The customer also mentioned that there was a quick spark on the cord and when they unplugged them, there was a quick burnt smell.Customer confirmed again that there was no harm or injury due to the event.21feb 2025, the customer confirmed they were referring to the power supply of the afinion instrument, not an external battery.Customer stated that the "leak" was coming from the power supply of the afinion 2 instrument serial number (b)(6).Both instruments were plugged in when they noticed the "leak stain" where the instruments were sitting on.Customer noticed the quick spark and quick burnt smell when they unplugged the af20081867; the spark was coming from the power supply plug, not the analyzer.

• Brand Name: AFINION 2
• Common Device Name: ANALYSER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer Contact: claire dora ; kjelsåsveien 161; po box 6863 rodelokka; oslo NO-05-04 ; NO NO-0504 ; 24056000
• MDR Report Key: 21586475
• Report Number: 9613069-2025-00002
• Device Sequence Number: 8757792
• Product Code: JQT
• UDI-Device Identifier: 07070060014692
• UDI-Public: (01)07070060014692
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 10441109
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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