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 Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

The customer found that the gravimetric test was failing.The customer replaced the syringe plunger assembly, which repaired the failing reagent tests.(b)(6).

Event Description

The customer reported the coulter tq-prep workstation was failing the gravimetric test for reagent c.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.

Manufacturer Narrative

Since there were no erroneous results there is no risk of injury upon recur of this event and per current procedures this would not have been a reportable event.The date of event and the date of this report were corrected from (b)(6) 2016 to (b)(6) 2016.

• 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: 6116375
• MDR Text Key: 60435561
• Report Number: 1061932-2016-00976
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• 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: 11/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2000
• 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