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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 08H67-03
Device Problem Charred (1086)
Patient Problem No Patient Involvement (2645)
Event Date 10/07/2014
Event Type  malfunction  
Event Description
The customer indicated that the cell-dyn ruby analyzer fan was not working.The field service engineer (fse) visited the customer site and observed that the top cover of the cell-dyn ruby analyzer was not the normal temperature.The fse opened the analyzer and upon inspection found that both fans were covered in soot.The fse replaced the fans.There was no report of any other damage or injury.
 
Manufacturer Narrative
(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
The customer reported that the celldyn ruby fans were not functioning.The field service engineer (fse) found the presence of soot on both of the fans.The fans were replaced and instrument performance was verified.Inspection of the returned parts (fans) found discoloration of the magnetic coils of the fan and the presence of spider webs.In addition, a burn mark was observed on the pcb, and the center column of each fan was found to be off-center, indicating overheating; however the cause of the overheating could not be determined.Customer complaint data was reviewed and no adverse trends were identified.Trending data does not indicate other fans being off center.The cell-dyn ruby operations manual was reviewed and was found to adequately address the issue.The investigation did not identify a product deficiency.
 
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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
Manufacturer (Section G)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key4218452
MDR Text Key5070622
Report Number2919069-2014-00070
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeRP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/07/2014
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 Number08H67-03
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/11/2014
Initial Date FDA Received10/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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