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

Model Number 750

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

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 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
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea, fl
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami, fl
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, mn ; 3681224
• MDR Report Key: 9866519
• MDR Text Key: 207569475
• Report Number: 1061932-2020-01933
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 750
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1