MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number 750

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2016, the field service engineer (fse) was at the customer site and observed that the customer's lh750 had a malfunctioning check valve at vl11 and that one of the rbc aperture was not working properly.Replacement of rbc tubing and the check valve at vl11 resolved the issue.It was not confirmed that patient results were impacted as a result of this event.Beckman coulter, in an abundance of caution, has submitted an mdr report.Patient information was not provided by the customer.(b)(4).Related event 1061932-2018-00039 (b)(4).

Event Description

The customer reported that their coulter lh 750 hematology analyzer was generating erroneous platelet results.It is unknown whether it was controls or patient samples that were impacted.Patient data was not provided by the customer.There was no report of change to patient treatment or affect to the patient as a result of this event.

• Brand Name: COULTER LH 750 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 ; 3107520824
• MDR Report Key: 7988085
• MDR Text Key: 124682305
• Report Number: 1061932-2018-00038
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 750
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 10/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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