MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF ANALYZER

Catalog Number 6706366

Device Problem Device Issue (2379)

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

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 12/04//2015, found a few drops of diluent had leaked from the probe wipe assembly onto the countertop below the probe due to broken tubing/fitting at the probe wipe assembly.The fse replaced the tubing/fitting and verified proper probe wipe operation without further leakage.The fse confirmed qc levels 1 and 2 within range.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported that the high level control was not passing for several parameters when run on their act diff instrument.There was no biohazard exposure to mucous membranes or open wounds.There was no death, injury, or change to patient treatment and no erroneous results were generated in connection with the reported event.

• Brand Name: COULTER AC·T DIFF ANALYZER
• Type of Device: COULTER AC·T DIFF ANALYZER
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5325065
• MDR Text Key: 34303555
• Report Number: 1061932-2015-01874
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973634
• 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
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 6706366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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