MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and discovered that the control module, induction heater showed evidence of burn/charring.The control module, induction heater was replaced and deemed the likely cause for the issue.A review of the analyzer¿s service history was performed and revealed no additional issues of burn odor and charred/burn parts reported on the isr03093.A review of tracking and trending did not identify any trends with regards to the current issue.The device history records were reviewed, and no non-conformances or potential non-conformances were identified.Labeling was reviewed and found to be adequate.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 burn odor and charring/burn observed was limited to control module, induction heater; the burn odor and charring/burn did not spread to other parts of the module.Based on the investigation, no systemic issue or deficiency of the architect i2000sr processing module serial number (b)(6) or the control module, induction heater were identified.
Event or Problem Description
The customer reported an error code 5394 (induction heating operation failed, device not ready) generated on the architect i2000sr processing module.The field service representative (fsr) inspected the instrument and noticed a smell of electrical burn near the hopper.Upon further inspection, the fsr found burnt induction heater controller.The fsr replaced the part to resolve the issue.There was no injury to the user reported.There was no impact to patient management reported.

• Brand Name: ARCHITECT I2000SR
• Common Device Name: 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: 20277455
• Report Number: 3016438761-2024-00556
• Device Sequence Number: 8012770
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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: 03M74-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2005
• 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