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	Improper Device Output (2953)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018, the field service engineer (fse) found that the apertures in the red blood count (rbc) bath were worn.The fse replaced the rbc bath and aperture to resolve the issue.The repairs were verified as per service procedure.Per a conversation with the fse on (b)(6) 2018 he confirmed that the instrument was generating abnormally high plt results for patient samples.The customer then reran the abnormally high results in another instrument which gave lower plt results that were considered correct.The customer confirmed to the fse that erroneous results were not reported outside of the laboratory.Patient information was not provided by the customer for this event.(b)(4).
Event or Problem Description
The customer reported that their coulter lh 500 hematology analyzer generated intermittent erroneous high platelet (plt) results on patient samples.There was no report of erroneous results reported out of the lab.There was no report of impact to patient treatment.Instrument printouts of patient results were 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: 7660393
• Report Number: 1061932-2018-01024
• Device Sequence Number: 13866166
• Product Code: GKZ
• UDI-Device Identifier: 15099590265045
• UDI-Public: (01)15099590265045(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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
• Distributor Facility Aware Date: 06/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/03/2018
• Patient Sequence Number: 1