MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	750
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was able to confirm the reported malfunction.The fse did not observe any bubbles in the instrument fluidics.To resolve the reported issue the fse verified the rbc bath connection and replaced the short tubing from the sweep flow canister to the bottom of the rbc aperture and clenz /isoton areas.Bec internal identifier(b)(4).
Event or Problem Description
Customer reported erratic high platelets on their coulter lh 750 hematology analyzer.The customer did not specify if the high platelets occured during controls or patient results.There was no report of change or effect to patient treatment as a result fo this event.The customer indicated that, "they have internal checks for elevated and (or) abnormal results, which includes patient history, running the same sample on the other instrument, and (or) making a manual slide etc.They feel confident that their internal procedures prevented any falsely elevated plt result from being released, and as far as they know, no patient was impacted" neither printouts for patient data or qc results were provided by the customer.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea, fl
• MDR Report Key: 9866519
• Report Number: 1061932-2020-01933
• Device Sequence Number: 14190978
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061574
• 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): 03/23/2020

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: 750
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1