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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
Catalog Number 09H39-01
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
 
Event Description
The account generated false elevated platelet of 1302 k/ul on a patient sample that repeated 430, 341, 297 k/ul when processing on the cell-dyn emerald.No impact to patient management was reported.No specific patient information was provided.
 
Manufacturer Narrative
Abbott field service representative (fsr) visited the site and noticed the instrument tubing looking very discolored.Further investigation found the syringe body and seal plate cracked.Fsr replaced tubing, syringe and seat plate, ran start up, precision and control, all recovered within specification.A service request record search for cd emerald analyzer, (b)(4), was performed.In addition, historical data and tracking and trending searches were performed.No adverse trends or product issues were found.A review of the product labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.
 
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Brand Name
CELL-DYN EMERALD
Type of Device
AUTOMATED HEMATOLOGY ANALYZER
Manufacturer (Section D)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
MDR Report Key7907354
MDR Text Key122470717
Report Number2919069-2018-00047
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740020088
UDI-Public00380740020088
Combination Product (y/n)N
PMA/PMN Number
K081495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/03/2018
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 Number09H39-01
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/29/2018
Initial Date FDA Received09/25/2018
Supplement Dates Manufacturer Received10/08/2018
Supplement Dates FDA Received11/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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