MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3700 SL ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number	02H31-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available information was included.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed smoke coming from the back of the cell-dyn 3700 analyzer.The instrument was turned off.No injury or exposure was reported.The field service engineer found evidence of fire on the pressure pump pcb relay card.
Additional Manufacturer Narrative
The investigation consisted of review of the complaint text, product historical data, and product labeling.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.The pcb assy, pump relay board is not available for return for investigation; however, a picture of the board was provided for review.The service engineer stated the instrument was performing properly after replacing the pcb assy, pump relay.The cell-dyn 3700 operator's manual, section 8, hazards, and section 9, service and maintenance, provides additional information related to this incident.A review of the product labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: CELL-DYN 3700 SL ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 7802605
• Report Number: 2919069-2018-00041
• Device Sequence Number: 1862108
• Product Code: GKZ
• UDI-Device Identifier: 00380740002725
• UDI-Public: 00380740002725
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K980614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 02H31-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1