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 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

On 25-mar-2016 the field service engineer (fse) was at the customer site and observed that the reported issue was occurring in manual mode.The fse took apart and cleaned the bsv (blood sampling valve) to resolve the issue.The repairs were verified per established procedures.The cause of the high plt results is attributed to an obstructed bsv.Section a - patient information was not provided by the customer.Beckman coulter is conducting a retrospective review of its global service records, to ensure that the records had been adequately evaluated for potential complaint information and any warranted follow-up action, including mdr reporting.  this mdr report is a result of that retrospective review.  (b)(4).

Event Description

The customer reported that their coulter lh 780 hematology analyzer was generating erratic platelet (plt) results and the controls were also biased high for platelets.The customer had not reported any erroneous results outside of the laboratory.There was no report of change or effect to patient treatment in connection with the reported event.The issue was reported as an ongoing issue for a two week period by the customer but they had not called to report it previous to this call.

• 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: 7726875
• MDR Text Key: 115655893
• Report Number: 1061932-2018-01008
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• Combination Product (y/n): N
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TN, LH780 ANALYTICAL STATION
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1