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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
Catalog Number 08H00-03
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
All available information was included.Additional details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
 
Event Description
During installation after downloading the aos firmware on the cell-dyn sapphire analyzer, upon restarting the instrument there was a burning smell from the machine and visible smoke.The instrument was shut down.On the data station, error 1421 laser current too high.The analyzer was not installed at the customer site.No injuries occurred.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs and a review of labeling.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.A definite cause was not identified, a few factors relating to the laser current, optics bench alignment and/or motion controller power supply could have cause the sim 1421 error.The analyzer was deinstalled.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
 
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Brand Name
CELL-DYN SAPPHIRE 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 Key8209326
MDR Text Key131826386
Report Number2919069-2019-00001
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740016623
UDI-Public00380740016623
Combination Product (y/n)N
Reporter Country CodeIT
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 04/01/2019
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
Device Operator Health Professional
Device Catalogue Number08H00-03
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/17/2018
Initial Date FDA Received01/02/2019
Supplement Dates Manufacturer Received03/28/2019
Supplement Dates FDA Received04/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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