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

Catalog Number	03M74-98
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 reported that the scc screen went black and would not restart.The customer reported a burning smell coming from the architect analyzer.There was no visible fire or smoke observed.The customer found that the scc power supply has a burn mark on it.There was no impact to patient management, user safety, or facility damage reported.
Additional Manufacturer Narrative
The field service engineer (fse) was dispatched to the account and identified a "burn mark" on the scc f+ power supply.The power supply was replaced to return the analyzer to normal function.A review of the architect, serial number (b)(4), service history found no contributing factor on or around the date of the event.There were no subsequent reports of smoke/burn of the scc f+ power supply after the part was replaced.A review of labeling 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 f+ power supply.The 2018 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 sparks from the scc f+ power supply (rohs) was limited to the power supply only and did not spread to other components.A review of similar complaints found no additional complaints and no trends were identified for the scc-f+ power supply (rohs) (part number 7-206072-01j-117).A review of alinity i / architect i2000sr complaints found no trends with regard to the current complaint issue.Based on the investigation no product deficiency was identified for either the architect (b)(4) or the scc-f+ power supply (rohs) (part number 7-206072-01j-117).

• 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: 8038045
• Report Number: 1628664-2018-01987
• Device Sequence Number: 16502778
• 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): 01/02/2019

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?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1