• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3700 SL ANALYZER; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7802605
MDR Text Key117858508
Report Number2919069-2018-00041
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740002725
UDI-Public00380740002725
Combination Product (y/n)N
PMA/PMN Number
K980614
Number of Events Reported1
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 Number02H31-01
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/01/2018
Initial Date FDA Received08/21/2018
Supplement Dates Manufacturer Received09/11/2018
Supplement Dates FDA Received10/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-