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

MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN SAPPHIRE SYSTEM; COUNTER, DIFFERENTIAL CELL

  • 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 LABORATORIES CELL-DYN SAPPHIRE SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 08H00-03
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/03/2022
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The account observed smoke coming from the back of the cell-dyn sapphire.The account stated after a strange sound from the left backside of the analyzer, smoke was seen and a strange odor.The account unplugged the power cord.The account technical service confirmed nothing was wrong with the wall socket or power at the account.No specific patient information provided as there was no patient involvement.No injury was reported.
 
Manufacturer Narrative
The likely cause part was the motion control power supply (mcps).The mcps part was replaced and qc recovered within specifications.A similar complaint review was performed showing no increase in complaint activity.A ticket trending review was performed showing no increase in complaint activity.No adverse trends were identified based upon the likely cause.No issues identified when reviewing corrective and preventative actions and non-conformances for the likely cause.The investigation included a review of product historical data, and product labeling.Review of historical data did not find a product issue related to the complaint incident.Labeling was found to be adequate for the complaint issue.No product deficiency was identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CELL-DYN SAPPHIRE SYSTEM
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
ABBOTT LABORATORIES
4551 great america parkway
santa clara CA 95054
Manufacturer (Section G)
ABBOTT LABORATORIES
4551 great america parkway
santa clara CA 95054
Manufacturer Contact
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key15029408
MDR Text Key304509106
Report Number2919069-2022-00020
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740016623
UDI-Public00380740016623
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K051215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/09/2022
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 Model Number08H00-03
Device Catalogue Number08H00-03
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/04/2022
Initial Date FDA Received07/15/2022
Supplement Dates Manufacturer Received08/22/2022
Supplement Dates FDA Received09/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-