MAUDE Adverse Event Report: BECKMAN COULTER COULTER EPICS XL-MCL FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6604988

Device Problem Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

The customer reported that eight sets of results were received for seven samples run on a coulter epics xl-mcl flow cytometer, and that one sample tube had been aspirated twice.Quality controls (qc) were run prior to the event and were within specification.No erroneous results were generated or reported in connection with this event.The customer is a stem cell harvesting facility.These results are used in the processing of stem cell harvesting procedures only.

Manufacturer Narrative

Data has been submitted and analyzed.The data shows that the instrument aspirated the first tube in the carousel twice producing results for the first and second sample in the carousel.This caused the other tubes in the carousel to be read and the results to be associated with the next higher tube in the carousel.This was a single isolated event.The customer set up the assay a second time and reran the samples producing valid results.The customer verified that the instrument was operating correctly after this event.A field service engineer (fse) was not dispatched on site for this event.(b)(4).

• Brand Name: COULTER EPICS XL-MCL FLOW CYTOMETER
• 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 ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 4633056
• MDR Text Key: 5594305
• Report Number: 1061932-2015-00530
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6604988
• Other Device ID Number: SOFTWARE VERSION: 3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2003
• 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