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

Catalog Number	02H31-03
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.Patient information: no patients involved.
Event or Problem Description
The customer reported that after system activation, smoke was observed from the cell-dyn 3700 sl analyzer.There was no report of injury or adverse impact to patient management.
Additional Manufacturer Narrative
The issue was resolved by replacing the power supply.A review of service tickets for the cell-dyn 3700 sl serial (b)(4) did not identify any tickets related to the issue.Review of complaint and trending data for the power supply did not identify any issues or trends associated with the customer's issue.A review of the cell-dyn 3700 sl tracking and trending data did not identify any adverse trends or abnormal complaint activity.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information and this investigation, no systemic issue or deficiency of the cell-dyn 3700 sl analyzer was identified.
Additional Manufacturer Narrative
The initial medical device report was submitted with an incorrect submission number in ind.The pma/510k was changed from k980614 to k991605.No further updates were necessary.

• 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: 8362894
• Report Number: 2919069-2019-00006
• Device Sequence Number: 1920897
• Product Code: GKZ
• UDI-Device Identifier: 00380740002732
• UDI-Public: 00380740002732
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K991605
• 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,Followup
• Report Date (Section B): 08/25/2019

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: 02H31-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 08/23/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/02/2019; 08/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1