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

Model Number TN, LH780 ANALYTICAL STATION

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018 the field service engineer was at the customer site and observed bubbles coming in from the fitting on the clenz input reservoir causing low mchc results.On (b)(6) 2018 the fse returned because the customer reported having low mchc results again.This visit the fse observed that in addition to the low mchc, the coulter lh 780 hematology analyzer was also generating high rbc and platelet results intermittently.The fse replaced the aspiration pump, cleaned and greased blood sampling valve (bsv) mechanism, rerouted the bsv tubing to remove possible stress points caused by the geared probe wipe assembly.Patient information was not provided by the customer.(b)(4).

Event Description

The customer reported having low mchc for patient samples on their coulter lh 780 hematology analyzer.Erroneous results were not reported outside of the laboratory.There was no change or effect to patient treatment as a result of this event.

• 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 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7708950
• MDR Text Key: 114708486
• Report Number: 1061932-2018-01028
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2013
• Device Model Number: TN, LH780 ANALYTICAL STATION
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/20/2018
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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