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

Model Number	AC*T DIFF 2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA
• MDR Report Key: 7920669
• Report Number: 1061932-2018-01045
• Device Sequence Number: 1913741
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K990352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: AC*T DIFF 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 09/28/2018
• Patient Sequence Number: 1