MAUDE Adverse Event Report: BECKMAN COULTER COULTER® HMX HEMATOLOGY ANALYZER W/ AUTOLOADER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605526

Device Problems Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

The customer reported that the diff mix chamber had become loose on their hmx autoloader instrument.It was making a loud sound.No death or injury is attributed to this event and no erroneous patient results were generated.

Manufacturer Narrative

A field service engineer (fse) was dispatched.The fse replaced the diff mixing chamber (mc1) resolving the reported issue.He also adjusted the probe wipe as preventative maintenance.Upon recur, the failure mode identified for improper mix chamber operation is likely to generate erroneous yet credible results for diff % and diff # (ly, mo, eo, ba and ne); results could be flagged, un-flagged or non-numeric.The manufacturer reference number for this event is (b)(4).

• Brand Name: COULTER® HMX HEMATOLOGY ANALYZER W/ AUTOLOADER
• 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: 3596186
• MDR Text Key: 4068400
• Report Number: 1061932-2014-00228
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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