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

Catalog Number	06P16-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed several instrument error messages on an alinity s analyzer.While the ambassador was troubleshooting the issues, charring was observed on the cicoil cable, which was replaced.There was no impact to patient management, user safety, or facility damage reported.There were no injuries 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
The customer observed several instrument error messages on an alinity s analyzer.While the ambassador was troubleshooting the issues, charring was observed on the cicoil cable, which was replaced.There was no impact to patient management, user safety, or facility damage reported.There were no injuries reported.
Additional Manufacturer Narrative
During troubleshooting on an alinity s system, serial number (b)(6).The abbott ambassador reported finding dark discoloration/charring on a cicoil cable.No fire was observed, and no injury occurred.The ambassador replaced the cable, s-r1 cicoil, part number b-30105525-06, which resolved the issue.The analyzer was returned to normal operation.The risk reduction for safety hazards on dallas-site diagnostic equipment and accessories contains information noting abbott diagnostic equipment and accessories are certified to the appropriate us, canadian, and international safety standards, and adequate protection is provided for the operator against electric shock or burn and the spread of fire from the equipment.Abbott diagnostic division performs an in-depth risk analysis which ensures that the overall residual risk is at an acceptable level.The evidence of charring of the cable, s-r1 cicoil, part number b-30105525-06, was limited to the cicoil and did not spread to other parts on the instrument.Device history record review did not identify any non-conformances or deviations.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.Based on the information provided and abbott diagnostics' complaint investigation, no systemic issue or product 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: 20993602
• Report Number: 1628664-2024-00008
• Device Sequence Number: 8135496
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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): Initial
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown