MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number AC*T DIFF 2

Device Problem High Test Results (2457)

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

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

The fse adjusted the calibration factors on the instrument to bring the plt results into the center of the range.The fse ran verification testing on the instrument, which all passed.The bec internal identifier for this event is case-(b)(4).

Event Description

The customer reported issues with platelet (plt) quality control results on a coulter ac·t diff 2 analyzer.The customer called customer technical support and refused to adjust their calibration values as recommended, adn requested service.The field service engineer (fse) evaluated the instrument at the customer's site and observed falsely elevated plt values on patient samples.Erroneous results were not released from the laboratory and there was no change or effect to patient treatment associated with this event.Patient results and patient demographic data were not provided by the customer for this event.

• Brand Name: COULTER AC·T DIFF 2 ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; 32-v11; miami, FL 33196-2031
• MDR Report Key: 7920669
• MDR Text Key: 123806735
• Report Number: 1061932-2018-01045
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990352
• 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: 09/28/2018

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: Health Professional
• Device Model Number: AC*T DIFF 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/11/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• Type of Device Usage: Unknown
• Patient Sequence Number: 1