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

Catalog Number 02H31-01

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

All available information was included.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 7802605
• MDR Text Key: 117858508
• Report Number: 2919069-2018-00041
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740002725
• UDI-Public: 00380740002725
• Combination Product (y/n): N
• PMA/PMN Number: K980614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 02H31-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1