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

Catalog Number 6605429

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

Patient Problem Not Applicable (3189)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

The customer observed that the sample tube did not have the correct amount of reagent when the sample was prep on the tq prep instrument.The sample line had aspirated air since the reagent bottles were empty.There was 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 both reagent sensors to resolve the issue.(b)(4).

Event Description

The fse (field service engineer) reported that the reagent sensors (reagent a and reagent b sensors) in a coulter tq-prep workstation failed and did not generate the low reagents messages.The customer performs the daily instrument check as per instructions for use and the customer visually confirms the tubes after preparation, which alerted the customer to the issue.Erroneous results were not generated and there was no change or effect to patient treatment in connection with this event.

• 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: 5088649
• MDR Text Key: 26207542
• Report Number: 1061932-2015-01480
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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