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

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.

• 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 Key: 9366582
• MDR Text Key: 195081917
• Report Number: 1061932-2019-01886
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590671525
• UDI-Public: (01)15099590671525(11)170303
• Combination Product (y/n): N
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• 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 Number: REMFG 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 Received: 11/22/2019
• 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 Number: 1
• Patient Age: 44 YR