MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 175356

Device Problems Thermal Decomposition of Device (1071); False Positive Result (1227); Smoking (1585)

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

Event Date 07/28/2014

Event Type  malfunction  

Event Description

The customer reported obtaining false small lymphocytes (sl) and small lymphocytes 1 (sl1) flags from the coulter act 5diff autoloader (al) hematology analyzer while running patient samples.No erroneous results were generated for this event.The customer did not provide any patient data, and there was no change to patient treatment in connection with this event.A beckman coulter (bec) field service engineer (fse) was working on the instrument to resolve the issue when the fse noticed a burning smell and a small amount of smoke from the instrument.There were no arcs, sparks, injury or static shock in association with this event.

Manufacturer Narrative

The fse determined that the burning smell and the small amount of smoke were associated with the main printed circuit board (pcb) that had shorted due to a corroded cable.The fse installed a new main board and cable to resolve this issue.The fse replaced the reagent syringes, mixing motor and heat block to resolve the flagging issue.(b)(4).

• Brand Name: COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
• 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
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 4039423
• MDR Text Key: 4729767
• Report Number: 1061932-2014-02045
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032013
• 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: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 175356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1