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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN EMERALD SYSTEM; COUNTER, DIFFERENTIAL CELL

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ABBOTT LABORATORIES CELL-DYN EMERALD SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 09H39-01
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2022
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely depressed hemoglobin results generated on the cell dyn emerald for one patient.The following data was provided: hgb result emerald 7.3 l / send out result 17.0 no impact to patient management was reported.
 
Manufacturer Narrative
The investigation included a review of the submitted data, product historical data, and product labeling.Trending review did not identify any trends for the complaint issue.Review of the background and qc results found that the results were within limits for all parameters; however, review of the precision report found that the %cv result for rdw was outside of the limits provided by the cell-dyn emerald operator¿s manual (9213301c¿december 2020).The operator¿s manual states that, "fresh whole blood specimens used to verify imprecision specifications should have mean values that fall within the range tested in [table 4.9]." "specimens with values outside these ranges may have higher or lower %cv." all other parameter were within range for precision.Review of the patient specimen reports from the cell-dyn emerald analyzer found that the wbc results were invalidated and flagged on both runs and the plt results were also flagged on 1 of 2 runs for patient 1, indicating that further review was required.The patient report from the analyzer for patient 2 was not available for review.The cell-dyn emerald operator¿s manual (9213301c¿december 2020), states that the wbc and plt measurand flags indicate that the, "result[s] may be suspect due to interfering substances or the inability of the instrument to measure a particular measurand due to a sample abnormality.The name of each flag, how it is displayed, the cause of the flag, and the action to be taken are given in [table 3.4 wbc flags and table 3.5 platelet flags]." the operator's manual also states that the, "cell-dyn emerald has been validated for its intended use.However, error can occur due to potential operator errors and system technology limitations.Results obtained from the system should be used with other clinical data, for example, patient symptoms, other test results, patient history, clinical impressions, information available from clinical evaluation, and other diagnostic procedures.All data should be considered for patient care management.If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." the operator's manual also provides steps on how to troubleshoot measurand related problems in section 10, "troubleshooting" in, "table 10.1 measurand-related problems." labeling was found to be adequate for the complaint issue.Trending review did not identify any trends for the complaint issue.
 
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Brand Name
CELL-DYN EMERALD SYSTEM
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
ABBOTT LABORATORIES
4551 great america parkway
santa clara CA 95054
Manufacturer (Section G)
ABBOTT LABORATORIES
4551 great america parkway
santa clara CA 95054
Manufacturer Contact
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key14789806
MDR Text Key300144427
Report Number2919069-2022-00016
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740020088
UDI-Public00380740020088
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/19/2022
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/31/2022
Initial Date FDA Received06/23/2022
Supplement Dates Manufacturer Received08/18/2022
Supplement Dates FDA Received08/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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