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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

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BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number REMFG TN,DXH 800 HEMATOLOGY SYSTEM
Device Problem Output Problem (3005)
Patient Problem Test Result (2695)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
A field service engineer (fse) was dispatched to inspect the instrument on 11/19/2019.The fse extracted the instrument files for the instrument in question.The fse has confirmed that there is no malfunction identified related to applications in the instrument.Additional data provided from qc and daily checks was reviewed.The data does not point out to an anomaly in instrument operation, the instrument was operating properly.Instrument files related to the unflagged result were provided by the customer and are in the process of being assessed for further determination of an assignable cause for the reported event.Patient weight was not provided by the customer.Ethnicity and race were not provided by the customer.Internal bec identifier case (b)(4).
 
Event Description
The customer reported that their unicel dxh 800 coulter cellular analysis system generated unflagged, questionably high platelet (plt) results for one patient diagnosed with dengue.The issue was identified by the clinician of the patient who was familiar with the patient's diagnosis and knew that previously reported plt results were moderately lower that the result in question.The results had originally been reported out of the lab, a retest was requested and results were corrected later.The was no impact to the patient or change to patient treatment.
 
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Brand Name
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECKMAN COULTER
250 s. kraemer blvd
brea CA 92821
Manufacturer (Section G)
BECKMAN COULTER
11800 sw 147th avenue
miami FL 33196 2031
Manufacturer Contact
laurie o'riordan
11800 sw 147th avenue
miami, FL 33196-2031
3053802874
MDR Report Key9366582
MDR Text Key195081917
Report Number1061932-2019-01886
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier15099590671525
UDI-Public(01)15099590671525(11)170303
Combination Product (y/n)N
PMA/PMN Number
K140911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/22/2019
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 Model NumberREMFG TN,DXH 800 HEMATOLOGY SYSTEM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/24/2019
Initial Date FDA Received11/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age44 YR
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