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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER
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ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
Catalog Number 08H67-01
Device Problem Sparking (2595)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
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 customer observed sparks and smoke from the cell-dyn ruby.The customer reported that a possible short circuit occurred inside the ups.The customer disconnected the power supply.No injuries were reported.No impact to patient management was reported.
 
Manufacturer Narrative
An investigation was performed for the customer issue and included a review of the complaint text, product historical data, and product labeling.Review of product historical data did not identify any adverse trends or abnormal complaint activity for this issue.Through the investigation it was determined that the complaint incident was specific to the external faulty non-abbott uninterrupted power supply.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.
 
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Brand Name
CELL-DYN RUBY ANALYZER
Type of Device
AUTOMATED HEMATOLOGY ANALYZER
Manufacturer (Section D)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
MDR Report Key8676143
MDR Text Key169927095
Report Number2919069-2019-00065
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740017170
UDI-Public00380740017170
Combination Product (y/n)N
PMA/PMN Number
K061667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number08H67-01
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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