MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 723585

Device Problems Device Operates Differently Than Expected (2913); Data Problem (3196)

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

Event Date 05/16/2014

Event Type  malfunction  

Event Description

Customer reported an error condition of voteouts (a non-numeric result) for the rbc (red blood cell) parameter was obtained during start-up when using the coulter lh 780 hematology analyzer.The rbc and platelet parameters were also failing to meet specifications during start-up.A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the analyzer.There was no report of erroneous test results associated with this event.There was no death, injury or affect to patient treatment.

Manufacturer Narrative

On (b)(4) 2014, the field service engineer (fse) evaluated the instrument and confirmed the blood sampling valve (bsv) was not rotating properly.The bsv shaft and lever were replaced.The fse also found a broken pinch valve, valve 11 (rbc count) which needed replacement, resolving the event.(b)(4).

• Brand Name: COULTER LH 780 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: 3858987
• MDR Text Key: 4459046
• Report Number: 1061932-2014-01300
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061616
• 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: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• 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