MAUDE Adverse Event Report: BECKMAN COULTER TQ-PREP WORKSTATION; STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Catalog Number 6605429

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

The customer reported low dispensing volume on the first tube prepped when using the tq-prep workstation.The tq-prep was delivering low volumes of reagents a (lyse) and b (quench) on the first tube prepped after powering up the unit.A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the system.There were no erroneous test results with this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

(b)(6).On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the system and replaced the syringes delivering reagents a and b in the instrument resolving the problem.(b)(4).

• Brand Name: TQ-PREP WORKSTATION
• Type of Device: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 4021681
• MDR Text Key: 4877167
• Report Number: 1061932-2014-01984
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605429
• Other Device ID Number: SOFTWARE VERSION: 1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2011
• 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