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	11/19/2024
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed z1 motor communication errors generated on the alinity s system.The instrument when trying to reinitialize, it instantly went into stop mode.The field service representative (fsr) arrived onsite to inspect the instrument and noticed that the sample probe 1 cicoil was burnt/charred.The fsr replaced the sample z1 cicoil.While running pipettor calibration target location check, sample z2 failed.Noticed that it was making a loud sound while moving.The fsr replaced the sample z2 motor.There was no harm or injuries reported.There was no impact to patient management reported.
Event or Problem Description
The customer observed z1 motor communication errors generated on the alinity s system.The instrument when trying to reinitialize, it instantly went into stop mode.The field service representative (fsr) arrived onsite to inspect the instrument and noticed that the sample probe 1 cicoil was burnt/charred.The fsr replaced the sample z1 cicoil.While running pipettor calibration target location check, sample z2 failed.Noticed that it was making a loud sound while moving.The fsr replaced the sample z2 motor.There was no harm or injuries reported.There was no impact to patient management reported.
Additional Manufacturer Narrative
The instrument was inspected and found the sample probe 1 cicoil to be warm and also to have one of its cables blackened.The cable, s-r1 cicoil was replaced and the instrument functioned as intended.An evaluation of the returned cable, s-r1 cicoil found a blackened cable visible under the insulation.The instrument service history review for (b)(6) identified no additional issues or contributing factors to the current complaint.A review of tracking and trending for the alinity s system did not identify any trends.A review of tracking and trending for the cable, s-r1 cicoil did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity s system for serial (b)(6) or the cable, s-r1 cicoil were 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: 20887204
• Report Number: 1628664-2024-00006
• Device Sequence Number: 8773424
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 12/30/2024

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CABLE, S-R1 CICOIL B-30105525-06; CABLE, S-R1 CICOIL B-30105525-06
• Patient Sex: Unknown