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

Model Number	TN, LH 500 (198-242/48-62)
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was on site and confirmed what the customer reported.The fse replaced the red/white processor board to resolve the issue.The fse verified instrument operation with startup, latron, controls and patient samples.All recovered within specification without error.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported intermittent high platelet (plt) results on startup, controls, and patient samples when cycled on their coulter lh 500 hematology analyzer.Patient data was requested but not provided for this event.The field service engineer (fse) confirmed that there were no erroneous platelet results released out of the laboratory.There was no death, injury or change to patient treatment due to this event.Information on whether the high plt results were flagged was requested but could not be confirmed.The fse did not know if the results in question were flagged.

• 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: 8742106
• Report Number: 1061932-2019-01681
• Device Sequence Number: 2296620
• Product Code: GKZ
• UDI-Device Identifier: 15099590265038
• UDI-Public: (01)15099590265038(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/27/2019

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: TN, LH 500 (198-242/48-62)
• Device Catalogue Number: 178834
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1