MAUDE Adverse Event Report: BECKMAN COULTER AC*T DIFF 2; 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported two patient samples recovered with a high platelet (plt) result when cycled on the act diff 2 instrument.The customer also reported start up failed for platelets following the event.No erroneous results reported out of the laboratory.There was no report of an injury or illness to the patient attributable to the output from the device in this event.No adverse event occurred.The customer reported two patient samples recovered with a high platelet (plt) result when cycled on the act diff 2 instrument.The customer also reported start up failed for platelets following the event.The failure mode is unknown.However, the replacement of the reagent pak resolved the event.
Additional Manufacturer Narrative
Section a patient information is not applicable.There was no impact to patients as a result of this event.The customer reported two patient samples recovered with a high platelet (plt) result when cycled on the act diff 2 instrument.The customer also reported start up failed for platelets following the event.No erroneous results reported out of the laboratory.There was no report of an injury or illness to the patient attributable to the output from the device in this event.No adverse event occurred.The failure mode is unknown.However, the replacement of the reagent pak resolved the event.Bec internal identifier - case-(b)(4).

• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kramer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 19605577
• Report Number: 1061932-2024-00005
• Device Sequence Number: 17772359
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)170526
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K973634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown