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

Model Number	TN, LH 500 (108-132/48-62)
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	11/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2016, the field service engineer (fse) was at the customer site and observed that the lh500 analytical instrument was generating plt vote outs.The fse found that the blood sampling valve (bsv) knob was broken.The fse replaced the bsv to resolve the issue.The repairs were verified as per service procedure.The failure mode for the reported event was a broken bsv knob.Patient information was not provided by the customer for this event.Beckman coulter is conducting a retrospective review of its global service records, to ensure that the records had been adequately evaluated for potential complaint information and any warranted follow-up action, including mdr reporting.  this mdr report is a result of that retrospective review.  bec internal identifier - (b)(4).
Event or Problem Description
The customer reported intermittent erratic high platelet results on their coulter lh 500 hematology analyzer.There was no report of erroneous results reported out of the lab from the provided information.There was no report of change or effect to patient treatment in connection with the reported event.Patient data was not provided by the customer for 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: 7727042
• Report Number: 1061932-2018-01011
• Device Sequence Number: 10988906
• Product Code: GKZ
• UDI-Device Identifier: 15099590265045
• UDI-Public: (01)15099590265045(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K042724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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: TN, LH 500 (108-132/48-62)
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2016
• Initial Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1