MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) ARCHITECT I2000SR ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Model Number	N/A
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/01/2020
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.
Event or Problem Description
The customer observed smoke and a burning smell coming from the scc power supply of the architect i2000sr when trying to power on the instrument multiple times.The smoke went away when the power was turned off.There was no impact to patient management, user safety, or facility damage reported.
Additional Manufacturer Narrative
The customer detected a burning odor and observed smoke coming from the power supply for the architect (sn: (b)(4)) after powering the module on.The smoke stopped when the module was turned off.All module activities stopped, and service was dispatched.No fire or damage to the instrument or injury to personnel was reported.The field service engineer (fse) was on site and replaced the power supply, scc (pn: 7-206072-01) with scc power supply (pn 7-206072-02) which resolved the issue.No fire was observed, and no injury occurred.A review of the architect (sn: (b)(4)) service history was performed and found no contributing factors and no subsequent reports of smoking from the scc power supply were reported.A review of trending data did not identify any trends for tickets with replacements of the power supply, scc (ln: 7-206072-01).A product labeling review found the architect system operations manual provides information regarding electrical hazards, and electrical safety for the architect systems.The i system service and support manual provides instructions for replacing the scc power supply.The 2020 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.There was no observed damage to the scc power supply.Based on the information, no systemic issue or deficiency was identified.

• Brand Name: ARCHITECT I2000SR ANALYZER
• Common Device Name: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10317233
• Report Number: 3016438761-2020-00140
• Device Sequence Number: 991542
• Product Code: JJE
• UDI-Device Identifier: 00380740068851
• UDI-Public: 00380740068851
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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 Model Number: N/A
• Device Catalogue Number: 03M74-98
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1