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

Model Number	780
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2018, the field service engineer (fse) was at the customer site and confirmed that the lh780 hematology analyzer was generating abnormal plt results.The fse replaced the platelet processor board assembly to resolve the issue.Patient information was not provided by the customer.(b)(4).
Event or Problem Description
The customer reported that their lh780 hematology analyzer generated plt voteouts and erroneous high platelet (plt) results on patient samples.Erroneous results were not reported outside of the laboratory.There was no report of impact or effect to patient treatment as a result of the reported event.The customer did not provide the patient data for 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: 7866776
• Report Number: 1061932-2018-01040
• Device Sequence Number: 13836848
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)160923
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/11/2018

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: 780
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1