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 01/30/2024

Event Type  malfunction  

Event Description

When the field service engineer turned on the alinity i processing module at the customer¿s site, a small amount of smoke was seen coming from the main power supply.No injuries or physical damage reported.No impact to patient management or user safety reported.

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Service determined the main power supply, processing module (part number a-30103383-01) the likely cause for observed smoke.The main power supply, processing module (part number a-30103383-03) was installed to replace part number a-30103383-01.Installation of the main power supply, processing module (part number a-30103383-03) resolved the issue.Return testing was not completed as returns were not available.A review of the alinity i processing module, serial number (b)(6) service history, revealed no additional issues of smoke from a part reported on the (b)(6).A review of tracking and trending did not find any related trends of the main power supply, processing module or the alinity i processing module with regards to the complaint issue.The device history record was reviewed and identified no non-conformances or deviations associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for the main power supply, processing module and the alinity i processing module, serial number (b)(6).

Event Description

When the field service engineer turned on the alinity i processing module at the customer¿s site, a small amount of smoke was seen coming from the main power supply.No injuries or physical damage reported.No impact to patient management or user safety reported.

• 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: 18680018
• MDR Text Key: 335071720
• Report Number: 3016438761-2024-00079
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MAIN POWER SUPPLY, PROCESSING MODULE, A-30103383-0; MAIN POWER SUPPLY, PROCESSING MODULE, A-30103383-0