MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 03R65-01

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed visible smoke coming from the alinity i processing module after a loud noise was heard.The instrument turned off and the power button stopped working.No injuries were reported.No impact to patient management was reported.

Event Description

The customer observed visible smoke coming from the alinity i processing module after a very loud noise was heard.The instrument turned off and the power button stopped working.No injuries were reported.No impact to patient management was reported.No harm to the user was reported.

Manufacturer Narrative

Updated section d4 - primary udi number from (b)(4).The field service representative (fsr) inspected and replaced the main power supply, processing module, which resolved the issue.Return testing was not completed as returns were not available.An instrument service history review revealed no additional issues of loud noises and smoke from a part reported on the (b)(6).A review of the tracking and trending of the alinity system and main power supply, processing module did not identify any trends associated with the complaint issue.The 2024 ul certification memo indicates that 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 loud noise and smoke observed was limited to main power supply, processing module; the loud noise and smoke did not spread to other parts of the module.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the alinity i processing module for serial ai04404 or main power supply, processing module was identified.

• Brand Name: ALINITY I PROCESSING MODULE
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18937796
• MDR Text Key: 338073585
• Report Number: 3016438761-2024-00167
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: 00380740137366
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R65-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1