MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	AC*T DIFF 2
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) confirmed the plt histogram was demonstrating spikes with an asterisk (*).The fse found that the lis was not in use and still connected to the act diff 2 instrument.The fse disconnected the unused lis and ran several samples ran with no plt spikes or ¿*¿ on the plt parameter.The instrument was verified by running daily check, controls with no further issues reported.Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported recovering asterisks (*) flags on the plt and mpv parameters for qc and patient samples run on the act diff 2 instrument.

• Brand Name: COULTER ACT DIFF ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 10255907
• Report Number: 1061932-2020-00111
• Device Sequence Number: 2842516
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/09/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1