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

Model Number	750
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	12/02/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 04-dec-2015 the field service engineer (fse) was at the customer site and did a cleaning and maintenance of the bath.He then proceeded to run several samples to ensure the instrument was running properly.This event was identified during a retrospective review of service requests.Although it was could not be confirmed if the platelet issue reported impacted patient results, beckman coulter, in an abundance of caution submitted a report for the event.(b)(4).
Event or Problem Description
Customer reported that platelet results were not correct on their coulter lh 750 hematology analyzer.The customer did not specify if the platelet issue occured during controls or patient results or whether they were high, low or voteouts.There was no report of change or effect to patient treatment as a result fo this event.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea FL 92821
• MDR Report Key: 7844999
• Report Number: 1061932-2018-00036
• Device Sequence Number: 13735570
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 750
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2015
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1