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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
Model Number 09H39-01
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported false decreased results for various hematology parameters when processing on the cell-dyn emerald.The following data was provided: 1st patient results from: (b)(6) 2019 and reference range: rbc: 2.16; 4.10-5.60.Hgb: 6.5; 11.5-17.0.Hct: 19.9; 34-50.0.Mcv: 92.3; 80-97.No flagging on wbc.(b)(6) 2019 and reference range: rbc: 2.16/2.4; 4.10-5.60.Hgb: 6.4/5.4; 11.5-17.0.Hct: 19.9/19.7; 34-50.0.Mcv: 91.7/92; 80-97.Wbc parameters have flaggings (*).(b)(6) 2019 and reference range: rbc: 3.45; 4.10-5.60.Hgb: 10.2; 11.5-17.0.Hct: 32.2; 34-50.0.Mcv: 93.4; 80-97.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, troubleshooting by field service engineer (fse), a review of product historical data, and a review of product labeling.The field service engineer found inconsistent rinse of sample probe through rinse head due to cable tie around tubing number 10 and 21 being tight.Cable tie was replaced, after which system operation appeared normal.A review of the product historical data did not identify any trends for this issue.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 EMERALD ANALYZER
Type of Device
AUTOMATED HEMATOLOGY ANALYZER
Manufacturer (Section D)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
MDR Report Key9369364
MDR Text Key184179349
Report Number2919069-2019-00111
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 01/27/2020
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 Model Number09H39-01
Device Catalogue Number09H39-01
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/30/2019
Initial Date FDA Received11/25/2019
Supplement Dates Manufacturer Received01/21/2020
Supplement Dates FDA Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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