MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed sparks when they tried to plug the ups back into the wall outlet connected to the alinity s processing module.The customer doing troubleshooting for lost power and noticed no power to ups.The spark was observed at the time when unplugged and reconnected the ups to the wall outlet.There was no patient involvement and no harm to user reported.No additional impact to user safety was reported.
Additional Manufacturer Narrative
A review of the alinity s system serial number: (b)(6), service history, revealed no additional issues of sparking (charring/burn) observed due to a part, reported on the (b)(6).A review of the instrument service history identified no additional issues or contributing factors to the current complaint.A review of complaint and trending data for the alinity s processing module did not identify any similar issues as described in this complaint.Additionally review of complaint and trending data associated with the uninterruptible power supply did not identify an increase in complaint activity.The alinity s system service documentation provides adequate information for electrical hazards during operation and maintenance and for the removal and replacement of the uninterruptible power supply (part number: 06a36-50).The alinity s system operations manual contains adequate information for performing an emergency shutdown on the instrument, regarding electrical hazards and for troubleshooting power interruptions.The 2025 ul certification contains information noting abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The spark observed was limited to uninterruptible power supply did not spread to other parts of the module.Based on the available information no product deficiency of the alinity s system serial number: (b)(6) or uninterruptible power supply was identified.
Event or Problem Description
The customer observed sparks when they tried to plug the ups back into the wall outlet connected to the alinity s processing module.The customer doing troubleshooting for lost power and noticed no power to ups.The spark was observed at the time when unplugged and reconnected the ups to the wall outlet.There was no patient involvement and no harm to user reported.No additional impact to user safety was reported.
Additional Manufacturer Narrative
This follow-up submission send for correction to section h6 adverse event problem: investigation findings code= to c13 from c19.Investigation conclusions=to c1401 from c14.A review of the alinity s system serial number: (b)(6), service history, revealed no additional issues of sparking (charring/burn) observed due to a part, reported on the (b)(6).A review of the instrument service history identified no additional issues or contributing factors to the current complaint.A review of complaint and trending data for the alinity s processing module did not identify any similar issues as described in this complaint.Additionally review of complaint and trending data associated with the uninterruptible power supply did not identify an increase in complaint activity.The alinity s system service documentation provides adequate information for electrical hazards during operation and maintenance and for the removal and replacement of the uninterruptible power supply (part number: 06a36-50).The alinity s system operations manual contains adequate information for performing an emergency shutdown on the instrument, regarding electrical hazards and for troubleshooting power interruptions.The 2025 ul certification contains information noting abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The spark observed was limited to uninterruptible power supply did not spread to other parts of the module.Based on the available information no product deficiency of the alinity s system serial number: (b)(6) or uninterruptible power supply was identified.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22035977
• Report Number: 1628664-2025-00005
• Device Sequence Number: 9411659
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: BL125674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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 Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 06/23/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/24/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2019
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNINTERRUPTIBLE POWER SUPPLY, 06A36-50, UNKNOWN.; UNINTERRUPTIBLE POWER SUPPLY, 06A36-50, UNKNOWN.; UNINTERRUPTIBLE POWER SUPPLY, 06A36-50, UNKNOWN.
• Patient Sex: Unknown