MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	TN, LH780 ANALYTICAL STATION
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	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) confirmed that platelets were running high and identified the rbc diluent dispenser as a potential cause.The fse replaced the rbc diluent dispenser and fixed a kink in the tubing leading from blood sampling valve (bsv) to rbc bath.The fse verified repairs by running qc and daily check.Results met published performance specifications.The instrument was considered operational at the conclusion of this service visit.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported that their lh780 analytical station has generated erratic high platelet (plt) results.Erroneous results were not reported outside of the lab.There was no change in patient treatment, or death or injury as a result of this event.

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 8719932
• Report Number: 1061932-2019-01674
• Device Sequence Number: 1993120
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)170818
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K061616
• 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): 06/20/2019

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, LH780 ANALYTICAL STATION
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/20/2019
• Patient Sequence Number: 1