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

Catalog Number	06P16-01
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sparks and smoke were reported coming from an alinity s system.It was reported that the analyzer was down for rsm theta motor failure on 8 apr 2025 when the sparks and smoke occurred.Upon inspection on 9 apr 2025 by field service engineer, fluid/contamination was noted and the rsm theta meridian controller had burn marks.Multiple analyzer parts were replaced.There were no injuries and no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
Sparks and smoke were reported coming from an alinity s system.It was reported that the analyzer was down for rsm theta motor failure on 8 apr 2025 when the sparks and smoke occurred.Upon inspection on 9 apr 2025 by field service engineer, fluid/contamination was noted and the rsm theta meridian controller had burn marks.Multiple analyzer parts were replaced.There were no injuries and no impact to patient management reported.
Additional Manufacturer Narrative
Alinity s system, serial # (b)(6) was evaluated.Analyzer troubleshooting found fluid near the igus chain and burn marks and evidence of dried fluid on the controller board.Further investigation found that r2 probe 1 was bent and positioned towards the controller board.Alnty pptr probes and integrated servo controller required replacement, which resolved the reported event.The investigation included a review of data and information provided by the customer, labeling review, search for similar complaints, ticket trending review, and device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search and trending review did not find an increase in complaint activity for the alnty pptr probes and integrated servo controller.Device history record review did not identify any issues for the alnty pptr probes and integrated servo controller.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency 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: 21922497
• Report Number: 1628664-2025-00003
• Device Sequence Number: 9021700
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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