MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number 1G06-11

Device Problem Smoking (1585)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

The customer reported hearing a loud noise while running samples on the architect c8000 processing module.The customer turned around and observed the screen was black and smoke coming from the scc (system control center) of the architect c8000 processing module.The modules were powered down immediately and all reagents were removed and stored in the refrigerator pending service.The scc power supply was replaced which resolved the issue.No reported impact to patient management or user safety was reported.

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.

Manufacturer Narrative

The field service representative (fsr) was dispatched due to the customer reporting a loud noise then the module¿s screen going black and the presence of smoke.No fire was seen nor any damage to the instrument.The loud noise and smoke observed was limited to power supply, scc-f+ (rohs).The loud noise and smoke did not spread to other parts of the module.The analyzer was powered down immediately.Service replaced the power supply, scc-f+ (rohs) and the power supply, scc-f+ (rohs) replacement resolved the issue.The module function was verified with a control/precision run.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and provides adequate information regarding the troubleshooting of the observed issue.The instrument service history review revealed no additional service tickets associated with discrepant/erratic results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of historical data found no non-conformances related to the current complaint.A review of tracking and trending for the power supply, scc-f+ (rohs) did not identify any trends.A review of tracking and trending data in the product monitoring review found no systemic issues or trends related to the issue described in the complaint.Based the investigation, no systemic issue or deficiency of the architect c8000 processing module for serial (b)(6)or the power supply, scc-f+ (rohs) was identified.

• Brand Name: ARCHITECT C8000
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15709217
• MDR Text Key: 303217689
• Report Number: 3016438761-2022-00503
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: 00380740000509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1G06-11
• Device Catalogue Number: 01G06-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POWER SUPPLY, SCC-F+ (ROHS), 7-206072-01, UNKNOWN; POWER SUPPLY, SCC-F+ (ROHS), 7-206072-01, UNKNOWN