MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	500
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2018, the field service engineer (fse) was at the customer site and observed a blocked aperture on the instrument that was causing the reported event.The fse removed the blockage and primed the diluent on the instrument to resolve the issue.Service activity performed is verified to meet the specified requirements per established procedures.The assignable cause of the reported event was a blocked aperture.Patient information was not provided by the customer.(b)(4).
Event or Problem Description
The customer reported that their coulter lh 500 hematology analyzer was generating erroneously high platelet (plt) results on patient samples.The customer has not reported any change or effect to patient treatment as a results of this event.

• Brand Name: COULTER LH 500 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 7745077
• Report Number: 1061932-2018-01037
• Device Sequence Number: 1365832
• Product Code: GKZ
• UDI-Device Identifier: 15099590265038
• UDI-Public: (01)15099590265038(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042724
• 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): 08/02/2018

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: 500
• Device Catalogue Number: 178834
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/05/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 08/02/2018
• Patient Sequence Number: 1