MAUDE Adverse Event Report: BECKMAN COULTER COULTER TQ-PREP WORKSTATION; AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO

Model Number N/A

Device Problems Failure to Sense (1559); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported a bad scatter pattern when samples were prepared on their tq prep instrument.The fse (field service engineer) observed a failure of the sensors.No error message alerted the customer that the reagent bottles were empty since the sensors had failed.The fse replaced the reagent a and reagent b level sense assemblies to resolve the issue.Repairs were verified per service procedures.The beckman coulter internal identifier for this event is (b)(4).

Event Description

The customer reported a bad scatter pattern when samples were prepared on their coulter tq-prep workstation.Erroneous results were not generated and there was no change or effect to patient treatment in connection with this event.Customer stopped using the instrument as soon as the problem was detected.

• Brand Name: COULTER TQ-PREP WORKSTATION
• Type of Device: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5957849
• MDR Text Key: 54995900
• Report Number: 1061932-2016-00815
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K130253
• 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6605429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2006
• 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