MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT I2000SR ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number	03M74-98
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/23/2016
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.An evaluation is in process.
Event or Problem Description
The customer observed smoke from the architect i2000sr analyzer system control center (scc).The customer stated that they smelled smoke, and when they opened the door where the scc is located, they saw visible smoke coming from the rear of the scc.No fire or other visible damage was seen.The analyzer and the scc were powered off.No fire or injury was reported.
Additional Manufacturer Narrative
An abbott field service representative (fsr) was dispatched to the account and found the failed component was the scc f+power supply (part number 7-206072-01) within the scc computer on the architect i2000sr analyzer.The smoke from the analyzer was limited to this part and did not spread to other parts of the equipment.The scc computer (part number 07d01-06) includes scc f+power supply (part number 7-206072-01).The fsr replaced the scc computer.The analyzer was returned to normal operation.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and a review of instrument service.Returned part was made available from the customer site for this evaluation.Inspection of the scc f+power supply (part number 7-206072-01) confirmed burn damage of a component on the circuit board inside the power supply.The damage was limited to this part and did not spread to other parts of the equipment.Architect i2000sr analyzer serial number (b)(4) service history was reviewed and no contributing factors were found.No subsequent reports of smoke/burn issues were identified after the scc computer was replaced.Product labeling was reviewed and found to be adequate.The issue was resolved through normal troubleshooting procedures.Based on all available information and abbott diagnostics complaint investigation for the architect i2000sr analyzer, no product deficiency was identified.

• Brand Name: ARCHITECT I2000SR ANALYZER
• Common Device Name: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6107261
• Report Number: 1628664-2016-00282
• Device Sequence Number: 13623639
• Product Code: JJE
• UDI-Device Identifier: 00380740068851
• UDI-Public: 00380740068851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K983212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2016

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: 03M74-98
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 12/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1