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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD ANALYZER; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
Catalog Number 09H39-01
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely elevated hematocrit results on the cell-dyn emerald analyzer.The following data was provided: initial 65 (patients normal value is 24).There was no impact to patient management reported.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The issue was resolved by replacing the sample piston, o-rings and tubing.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
 
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Brand Name
CELL-DYN EMERALD ANALYZER
Type of Device
AUTOMATED HEMATOLOGY ANALYZER
Manufacturer (Section D)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
MDR Report Key8605686
MDR Text Key145519450
Report Number2919069-2019-00063
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 06/06/2019
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 Number09H39-01
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/29/2019
Initial Date FDA Received05/13/2019
Supplement Dates Manufacturer Received06/04/2019
Supplement Dates FDA Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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